ELEVIDYS- delandistrogene moxeparvovec-rokl kit

ELEVIDYS by

Drug Labeling and Warnings

ELEVIDYS by is a Prescription medication manufactured, distributed, or labeled by Sarepta Therapeutics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • BOXED WARNING (What is this?)

    WARNING: ACUTE SERIOUS LIVER INJURY AND ACUTE LIVER FAILURE

    • Acute serious liver injury, including life-threatening and fatal acute liver failure, has occurred with ELEVIDYS [see Warnings and Precautions (5.1)].
    • Patients with preexisting liver impairment may be at higher risk [see Warnings and Precautions (5.1)].
    • Prior to infusion, assess liver function by clinical examination and laboratory testing. Administer systemic corticosteroids before and after ELEVIDYS infusion. Continue to monitor liver function weekly for the first 3 months after infusion and continue until results are unremarkable [see Dosage and Administration (2.1, 2.2, 2.4)].
    • Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion [see Dosage and Administration (2.1)].
    • Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected [see Dosage and Administration (2.2), Warnings and Precautions (5.1)].
  • 1 INDICATIONS AND USAGE

    ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].

    Limitations of Use:

    ELEVIDYS is not recommended in patients with:

    • Preexisting liver impairment (defined as gamma-glutamyl transferase [GGT] > 2 x upper limit of normal or total bilirubin > the upper limit of normal not due to Gilbert's syndrome) or active hepatic viral infection due to the high risk of acute serious liver injury and acute liver failure.
    • Recent vaccination (within 4 weeks of treatment) due to immunogenicity and potential safety concerns.
    • Active or recent (within 4 weeks) infections due to safety concerns.
  • 2 DOSAGE AND ADMINISTRATION

    For single-dose intravenous infusion only.

    2.1 Critical Dosing Information

    • Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by the healthcare provider, for at least 2 months following ELEVIDYS infusion.
    • Prior to ELEVIDYS infusion:
      • Select patients for treatment with ELEVIDYS with anti-AAVrh74 total binding antibody titers <1:400. An FDA-authorized test for the detection of anti-AAVrh74 total binding antibodies is not currently available. Currently available tests may vary in accuracy and design.
      • Avoid ELEVIDYS administration in patients with elevated anti-AAVrh74 total binding antibody titers (≥1:400) [Clinical Pharmacology (12.6)].
      • Due to the increased risk of serious systemic immune response, postpone ELEVIDYS in patients with active or recent (within 4 weeks) infections [see Warnings and Precautions (5.2)].
      • Assess liver function (clinical examination and laboratory testing including aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), albumin, activated partial thromboplastin time (aPTT), international normalized ratio (INR), and total bilirubin) [see Dosage and Administration (2.4), Warnings and Precautions (5.1), Use in Specific Populations (8.6)].
      • Obtain platelet count and troponin-I levels [see Dosage and Administration (2.4), Warnings and Precautions (5.3)].
    • Do not re-administer ELEVIDYS.

    2.2 Recommended Dose

    The recommended dose of ELEVIDYS is 1.33 × 1014 vector genomes per kilogram (vg/kg) of body weight (or 10 mL/kg body weight) for patients weighing less than 70 kg or 9.31 × 1015 vg total fixed dose for patients weighing 70 kg or greater.

    For the number of vials required, refer to Table 10 [see How Supplied/Storage and Handling (16.1)].

    Calculate the dose as follows:

    ELEVIDYS dose (in mL) = patient body weight (rounded to the nearest kilogram) x 10

    The multiplication factor 10 represents the per kilogram dose (1.33 × 1014 vg/kg) divided by the amount of vector genome copies per mL of the ELEVIDYS suspension (1.33 × 1013 vg/mL).

    Number of ELEVIDYS vials needed = ELEVIDYS dose (in mL) divided by 10.

    Example: Calculation of volume needed for a 19.5 kg patient
               19.5 kg rounded to the nearest kilogram = 20 kg
               20 kg × 10 = 200 mL

    Number of ELEVIDYS vials needed = 200 divided by 10, rounded to the nearest number of vials = 20 vials

    Administer corticosteroids to reduce the risk of immune responses to the AAVrh74 vector after administration of ELEVIDYS [see Clinical Pharmacology (12.6)]. Start corticosteroids 1 day prior to ELEVIDYS infusion based on the schedule outlined in Table 1 below. Continue this regimen for a minimum of 60 days after the infusion, unless earlier tapering is clinically indicated.

    Table 1: Recommended pre- and post-infusion oral corticosteroid dosing

    a Patient continues to receive this dose

    b Corticosteroids other than prednisone and prednisolone have not been studied for use as a peri-ELEVIDYS infusion corticosteroid

    Baseline corticosteroid dosingaPeri-ELEVIDYS infusion corticosteroid dose (prednisone equivalent)bRecommended maximum total daily oral dose
    (prednisone equivalent) b
    Daily or intermittent dose Start 1 day prior to infusion:
    1 mg/kg/day (and continue baseline dose)     		60 mg/day
    High dose for 2 days per week Start 1 day prior to infusion:
    1 mg/kg/day taken on days without high-dose corticosteroid treatment (and continue baseline dose)     		60 mg/day
    Not on corticosteroids Start 1 week prior to infusion:
    1.5 mg/kg/day     		60 mg/day

    Modify oral corticosteroid doses according to Table 2 for patients with liver function abnormalities (e.g., GGT >= 3 times baseline, total bilirubin > ULN) following ELEVIDYS infusion. Consider IV bolus corticosteroids instead of oral corticosteroids for GGT or bilirubin elevations that do not respond after 1 week of increased oral corticosteroids. Consult with a specialist experienced in immunosuppressive therapy for additional interventions as needed.

    Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected.

    Taper the additional peri-ELEVIDYS corticosteroids for patients previously taking corticosteroids at baseline back to baseline dose over 2 weeks, or longer as needed. Taper the peri-ELEVIDYS corticosteroids for patients not previously taking corticosteroids at baseline back to no corticosteroids over 4 weeks, or longer as needed. Do not stop corticosteroids abruptly.

    Table 2: Recommended oral corticosteroid regimen dose modification for liver function abnormalities following ELEVIDYS infusiona
    Peri-ELEVIDYS infusion corticosteroid dosingModified oral corticosteroid dose following ELEVIDYS infusion (prednisone equivalent)b cRecommended maximum total daily oral dose
    (prednisone equivalent)b c

    a GGT >= 3 times baseline and/or other clinically significant liver function abnormalities (e.g., total bilirubin > ULN) following infusion.

    b Consider IV bolus corticosteroids instead of oral corticosteroids for GGT or bilirubin elevations that do not respond after 1 week of increased oral corticosteroids. Consult with a specialist experienced in immunosuppressive therapy for additional interventions as needed.

    c Corticosteroids other than prednisone and prednisolone have not been studied for use as a peri-ELEVIDYS infusion corticosteroid.

    Baseline + 1 mg/kg/day
    		Increase to 2 mg/kg/day (and continue baseline dose) 120 mg/day
    Baseline + 1 mg/kg/day taken on days without high-dose corticosteroid
    treatment     		Increase to 2 mg/kg/day taken on days without high-dose corticosteroid treatment (and continue baseline dose) 120 mg/day
    1.5 mg/kg/day Increase from 1.5 mg/kg/day to 2.5 mg/kg/day 120 mg/day

    2.3 Preparation

    General precautions

    • Prepare ELEVIDYS using aseptic technique.
    • Verify the required dose of ELEVIDYS based on the patient's body weight.
    • Confirm that the kit contains sufficient number of vials to prepare the ELEVIDYS infusion for the patient.
    • Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever suspension and container permit. ELEVIDYS may contain white to off-white particles.

    Recommended supplies and materials:

    • 60 mL siliconized polypropylene syringes
    • 21-gauge maximum or smaller stainless steel needles

    Preparing ELEVIDYS infusion

    1. Thaw ELEVIDYS before use.
      • When thawed in the refrigerator, ELEVIDYS vials are stable for up to 14 days in the refrigerator (2°C to 8°C [36º F to 46º F]) when stored in the upright position.
      • Frozen ELEVIDYS vials will thaw in approximately 2 hours when placed at room temperature (up to 25°C [77ºF]) when removed from original packaging.
      • Thawed ELEVIDYS is stable for up to 24 hours at room temperature (up to 25°C [77ºF]).
    2. Inspect vials to ensure no ice crystals are present prior to preparation.
    3. When thawed, swirl gently.
      • Do not shake.
      • Do not refreeze.
      • Do not place back in the refrigerator.
    4. Visually inspect each vial of ELEVIDYS. ELEVIDYS is a clear, colorless liquid that may have some opalescence. ELEVIDYS may contain white to off-white particles.
      • Do not use if the suspension in the vials is cloudy or discolored.
    5. Remove the plastic flip-off cap from the vials and disinfect the rubber stopper with a sterilizing agent (e.g., alcohol wipes).
    6. Withdraw 10 mL of ELEVIDYS from each vial provided in the customized ELEVIDYS kit (refer to Table 10).
      • Do not use filter needles during preparation of ELEVIDYS.
      • Multiple syringes will be required to withdraw the required volume.
      • Remove air from the syringes and cap the syringes.
    7. Maintain syringes at room temperature prior to and during administration.

    2.4 Administration

    Recommended supplies and materials:

    • Syringe infusion pump
    • 0.2-micron PES* in-line filter with a large surface area. To avoid the risk of occlusions, the use of smaller pediatric in-line filters (e.g., less than 10 cm2 surface area) is not recommended.
    • PVC* (non-DEHP*) IV infusion tubing, and polyurethane catheter

    *PVC = Polyvinyl chloride, DEHP = Di(2-ethylhexyl) phthalate, PES = Polyether sulfone

    Administer ELEVIDYS as a single-dose intravenous infusion through a peripheral venous catheter:

    ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available [see Warnings and Precautions (5.4)]. Do not infuse ELEVIDYS at a rate of 10 mL/kg/hour or faster.

    Consider application of a topical anesthetic to the infusion site prior to administration of IV insertion.

    Recommend inserting a back-up catheter.

    1. Flush the intravenous access line with 0.9% Sodium Chloride Injection prior to the ELEVIDYS infusion at the same infusion rate.
    2. Administer ELEVIDYS via intravenous infusion using a syringe infusion pump with an in-line 0.2-micron filter at a duration of approximately 1 to 2 hours, or longer at care team discretion, through a peripheral limb vein.
    3. Infuse at a rate of less than 10 mL/kg/hour.
      • Do not administer ELEVIDYS as an intravenous push.
      • Do not infuse ELEVIDYS in the same intravenous access line with any other product.
      • Use ELEVIDYS within 12 hours after drawing into syringe. Discard the ELEVIDYS-containing syringe(s) if infusion of the drug has not been completed within the 12-hour timeframe.
    4. In the event of an infusion-related reaction during administration [see Warnings and Precautions (5.4)]:
      • Slow or stop the infusion based on patient's clinical presentation.
      • Discontinue infusion for anaphylaxis.
      • Administer treatment as needed to manage infusion-related reaction.
      • ELEVIDYS infusion may be restarted at a lower rate after the infusion-related reaction has resolved at the discretion of the physician, based on severity of patient's clinical presentation.
      • If the ELEVIDYS infusion needs to be stopped and restarted, ELEVIDYS should be infused within 12 hours after drawing into the syringe [see How Supplied/Storage and Handling (16.2)].
    5. Flush the intravenous access line with 0.9% Sodium Chloride Injection after the ELEVIDYS infusion.
      • Discard unused ELEVIDYS [see How Supplied/Storage and Handling (16.2)].
      • Dispose of the needle and syringe [see How Supplied/Storage and Handling (16.2)].

    Monitoring Post-ELEVIDYS Administration

    • Assess liver function (clinical exam, AST, ALT, GGT, albumin, aPTT, INR, and total bilirubin) weekly for the first 3 months. Continue monitoring if clinically indicated, until results are unremarkable (e.g., normal clinical exam, GGT and total bilirubin levels return to near baseline levels) [see Warnings and Precautions (5.1), Specific Populations (8.6)].
    • Obtain platelet counts weekly for the first two weeks [see Adverse Reactions (6.1)]. Continue monitoring if clinically indicated.
    • Measure troponin-I weekly for the first month [see Warnings and Precautions (5.3)]. Continue monitoring if clinically indicated, until results return to near baseline levels or stabilize.
  • 3 DOSAGE FORMS AND STRENGTHS

    ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles.

    ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 × 1013 vg/mL.

    ELEVIDYS is provided in a customized kit containing ten to seventy 10 mL single-dose vials, with each kit constituting a dosage unit based on the patient's body weight [see How Supplied/Storage and Handling (16.1)].

  • 4 CONTRAINDICATIONS

    ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene [see Warnings and Precautions (5.5)].

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Acute Serious Liver Injury and Acute Liver Failure

    Acute serious liver injury marked by elevations of liver enzymes (e.g., GGT, ALT) and total bilirubin and acute liver failure, has occurred with ELEVIDYS. Onset of the liver injury typically begins within 8 weeks after administration of ELEVIDYS. In non-ambulatory patients treated with ELEVIDYS, acute liver failure with fatal outcome has occurred in the clinical and post-marketing settings.

    Life-threatening mesenteric vein thrombosis, complicated by bowel ischemia and necrosis, and portal hypertension have been reported following acute liver injury associated with ELEVIDYS in a non-ambulatory patient [see Adverse Reactions (6.2)].

    Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury or acute liver failure. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Patients with hepatic impairment, acute liver disease, chronic hepatic condition or elevated GGT have not been studied in clinical trials with ELEVIDYS [see Specific Populations (8.6)].

    In clinical studies, liver function test increased (including increases in GGT, ALT, AST, or total bilirubin) was commonly reported typically within 8 weeks following ELEVIDYS infusion, with the majority of cases being asymptomatic [see Adverse Reactions (6.1)]. Most cases resolved spontaneously or with systemic corticosteroids and resolved without clinical sequelae within 2 months.

    Prior to ELEVIDYS administration, perform liver enzyme test [see Dosage and Administration (2.1)]. Monitor liver function (clinical examination, AST, ALT, GGT, albumin, aPTT, INR, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (e.g., normal clinical exam, GGT and total bilirubin levels return to near baseline levels) [see Dosage and Administration (2.4)].

    Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion [see Dosage and Administration (2.2)]. Adjust corticosteroid regimen when indicated [see Dosage and Administration (2.2)]. Obtain prompt consultation with a specialist (e.g., gastroenterologist or hepatologist) if acute serious liver injury or impending acute liver failure is suspected.

    5.2 Serious Infections

    Increased susceptibility to serious infections may occur due to concomitant administration of corticosteroid regimen and additional immunosuppressants, and ELEVIDYS. Serious respiratory infections, including with fatal outcomes, have occurred in patients taking immunosuppressant corticosteroids required for ELEVIDYS administration [see Adverse Reactions (6.2)].

    Monitor patients for signs and symptoms of infection before and after ELEVIDYS administration and treat appropriately. Administer immunizations according to best clinical practices and immunization guidelines prior to initiation of the corticosteroid regimen required before ELEVIDYS infusion [see Drug Interactions (7)].

    Avoid administration of ELEVIDYS to patients with active infections.

    5.3 Myocarditis

    Acute, serious, life-threatening myocarditis and troponin-I elevations have been observed within 24 hours to more than 1 year following ELEVIDYS infusion [see Adverse Reactions (6.1)].

    If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Patients with moderate to severe LVEF impairment have not been studied in clinical trials with ELEVIDYS.

    Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion [see Dosage and Administration (2.4)]. Continue monitoring if clinically indicated, until results return to near baseline levels or stabilize. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath.

    Advise patients to contact a physician immediately if they experience cardiac symptoms.

    5.4 Infusion-related Reactions

    Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during and for at least 3 hours after the end of infusion for signs and symptoms of infusion-related reactions including tachycardia, tachypnea, lip swelling, difficulty breathing, nasal flaring, urticaria, flushing, lip pruritus, rash, cheilitis, vomiting, nausea, rigors and pyrexia.

    ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available.

    In the event of an infusion-related reaction, administration of ELEVIDYS may be slowed or stopped based on the severity of the patient's clinical presentation. Administer treatment as needed to manage infusion-related reactions based on the severity of patient's signs and symptoms. [see Dosage and Administration (2.4)]. If the infusion was stopped, ELEVIDYS infusion may be restarted at a lower rate once patient's symptoms have resolved, at the discretion of the physician. Discontinue infusion for anaphylaxis.

    5.5 Immune-mediated Myositis

    Immune-mediated myositis, including serious and life-threatening events, has occurred approximately 1 month following ELEVIDYS infusion [see Adverse Reactions (6)]. Signs and symptoms include severe muscle weakness, including dysphagia, dyspnea, dysphonia, and hypophonia.

    These immune reactions may be due to a T-cell based response against specific regions of the micro-dystrophin transgenic protein. Severe to life-threatening immune-mediated myositis has been reported in patients with deletions including portions of exons 1-17 and/or exons 59-71 of the DMD gene. ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9, including a deletion of any portion or the entirety of these exons, in the DMD gene due to the increased risk for a severe immune-mediated myositis reaction [see Contraindications (4)].

    Regardless of genetic mutation, advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, dysphonia, or hypophonia as these may be symptoms of myositis. Consider additional immunomodulatory treatment based on patient's clinical presentation and medical history if these symptoms occur.

    5.6 Pre-existing Immunity against AAVrh74

    In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS all patients developed anti-AAVrh74 antibodies. Perform baseline testing for the presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration [see Dosage and Administration (2.1)].

    ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers (≥1:400).

  • 6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    The safety data described in this section reflect exposure to a one-time intravenous infusion of ELEVIDYS in 156 male patients with a confirmed mutation of the DMD gene in four clinical studies, including one completed open-label study, one ongoing open-label study, and two studies that included a double-blind, placebo-controlled period. Prior to ELEVIDYS infusion, patients in the ELEVIDYS treatment group had a mean age of 6.7 years (range: 3 to 20) and mean weight of 24.6 kg (range: 12.5 to 80.1). 144 patients received the recommended dose of 1.33 × 1014 vg/kg, and 12 received a lower dose. Table 3 below presents adverse reactions from these four clinical studies.

    The most common adverse reactions (incidence ≥5%) across all studies are summarized in Table 3.

    Adverse reactions were typically seen within the first 2 weeks (nausea, vomiting, thrombocytopenia, pyrexia), the first month (myocarditis, troponin-I increased) or within the first 2 months (immune-mediated myositis, liver injury). Vomiting may occur as early as on the day of the infusion.

    Table 3. Adverse reactions (Incidence ≥5%) following treatment with ELEVIDYS in Clinical Studies
    Adverse reactionsELEVIDYS
    (N=156) %

    a Includes: AST increased, ALT increased, GGT increased, GLDH increased, GLDH level abnormal, Hepatotoxicity, Hepatic enzyme increased, Hypertransaminasemia, Liver function test increased, Liver injury, Transaminases increased, Blood bilirubin increased

    b Includes: Thrombocytopenia, Platelet count decreased

    c Transient, mild, asymptomatic decrease in platelet counts

    d Includes: Troponin I increased, Troponin increased, Troponin I abnormal

    Vomiting 65
    Nausea 43
    Liver injurya40
    Pyrexia 28
    Thrombocytopeniab c8
    Troponin-I increased d8

    In clinical trials, immune-mediated myositis was observed in 2 of 6 patients with deletion mutations involving exon 8 and/or 9 in the DMD gene [see Contraindications (4), and Warnings and Precautions (5.5)].

    In the double-blind, placebo-controlled trial, Study 3 Part 1, patients 4 to 7 years of age (N=125) received either ELEVIDYS (N=63) at the recommended dose of 1.33 × 1014 vg/kg or placebo (N=62). Table 4 below presents the most frequent adverse reactions from Study 3 Part 1.

    Table 4. Adverse reactions occurring in ELEVIDYS-treated patients and at least twice more frequently than with placebo in Study 3 Part 1

    a Includes: AST increased, ALT increased, GGT increased, GLDH increased, GLDH level abnormal, Hepatotoxicity, Hepatic enzyme increased, Hypertransaminasemia, Liver function test increased, Liver injury, Transaminases increased.

    b Includes: platelet count decreased, thrombocytopenia

    c Transient, mild, asymptomatic decrease in platelet counts

    Adverse reactionsELEVIDYS
    (N=63) %    		Placebo
    (N=62) %
    Vomiting 64 19
    Nausea 40 13
    Liver injurya41 8
    Pyrexia 32 24
    Thrombocytopeniabc3 0

    6.2 Postmarketing Experience

    The following adverse reactions have been identified during post-approval use of ELEVIDYS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Hepatobiliary Disorders: Acute liver injury, acute liver failure, including fatal outcome and life-threatening mesenteric vein thrombosis [see Warnings and Precautions (5.1)]

    Infections and Infestations: Bacterial and viral respiratory infections, including fatal outcome [see Warnings and Precautions (5.2)]

    Immune System Disorders: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration [see Warnings and Precautions (5.4)].

    Musculoskeletal and connective tissue disorders: Immune-mediated myositis [see Warnings and Precautions (5.5)].

  • 7 DRUG INTERACTIONS

    Prior to initiating the corticosteroid regimen required before ELEVIDYS administration, consider the patient's vaccination status. Patients should, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines. Vaccinations should be completed at least 4 weeks prior to initiation of the corticosteroid regimen.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    ELEVIDYS is not intended for use in pregnant women.

    In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

    8.2 Lactation

    Risk Summary

    There is no information available on the presence of ELEVIDYS in human milk, the effects on the breastfed infant, or the effects on milk production.

    8.4 Pediatric Use

    The safety and effectiveness of ELEVIDYS for the treatment of Duchenne muscular dystrophy has been established in pediatric patients at least 4 years of age with a confirmed mutation in the DMD gene. The use of ELEVIDYS in pediatric patients was supported by evidence from three adequate and well controlled clinical studies which included 144 pediatric patients aged 4 years of age and older [see Adverse Reactions (6), Clinical Pharmacology (12.2), Clinical Studies (14)].

    8.5 Geriatric Use

    The safety and efficacy of ELEVIDYS in geriatric patients with DMD have not been studied.

    8.6 Hepatic Impairment

    The safety and efficacy of ELEVIDYS in patients with hepatic impairment or elevated GGT have not been studied.

    Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Treatment with ELEVIDYS should be carefully considered in patients with preexisting liver impairment or chronic hepatic viral infection. These patients may be at increased risk of acute serious liver injury or acute liver failure [see Warnings and Precautions (5.1)].

    In clinical trials, liver function test increase was commonly reported in patients following ELEVIDYS infusion [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].

  • 11 DESCRIPTION

    ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells.

    ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    ELEVIDYS is the recombinant gene therapy product that is comprised of a non-replicating, recombinant, adeno-associated virus (AAV) serotype rh74 (AAVrh74) capsid and a single-stranded DNA expression cassette flanked by inverted terminal repeats (ITRs) derived from AAV2. The cassette contains: 1) an MHCK7 gene regulatory component comprising a creatine kinase 7 promoter and an α-myosin heavy chain enhancer, and 2) the DNA transgene encoding the engineered micro-dystrophin protein.

    Vector/Capsid: Clinical and nonclinical studies have demonstrated AAVrh74 serotype transduction in skeletal muscle cells. Additionally, in nonclinical studies, AAVrh74 serotype transduction has been demonstrated in cardiac and diaphragm muscle cells.

    Promoter: The MHCK7 promoter/enhancer drives transgene expression and has been shown in animal models to drive transgenic micro-dystrophin protein expression predominantly in skeletal muscle (including diaphragm) and cardiac muscle. In clinical studies, muscle biopsy analyses have confirmed micro-dystrophin expression in skeletal muscle.

    Transgene: DMD is caused by a mutation in the DMD gene resulting in lack of functional dystrophin protein. ELEVIDYS carries a transgene encoding a micro-dystrophin protein consisting of selected domains of dystrophin expressed in normal muscle cells.

    ELEVIDYS micro-dystrophin has been demonstrated to localize to the sarcolemma.

    12.2 Pharmacodynamics

    In 92 patients who received ELEVIDYS in clinical studies, micro-dystrophin protein expression from muscle biopsies (gastrocnemius or biceps brachii) was quantified by western blot and localized by immunofluorescence staining (fiber intensity and percentage micro-dystrophin).

    Micro-dystrophin expression (expressed as change from baseline) in ELEVIDYS-treated patients as measured by western blot was the primary objective of Study 1 and Study 2, and a key secondary objective for Study 3. Muscle biopsies were obtained at baseline prior to ELEVIDYS infusion and at Week 12 after ELEVIDYS infusion in all patients. The absolute quantity of micro-dystrophin was measured by western blot assay, adjusted by muscle content and expressed as a percent of control (levels of wild-type dystrophin in patients without DMD or Becker muscular dystrophy) in muscle biopsy samples. Study 1 and 2 results of patients receiving 1.33 × 1014 vg/kg ELEVIDYS are presented in Table 5.

    Table 5. Micro-Dystrophin Expression in Study 1 and Study 2 at Week 12 from Baseline (Western Blot Assay)abc
    Western blot (% of micro-dystrophin compared to control)Study 1
    Part 1
    (n=6)    		Study 1
    Part 2
    (n=21)    		Study 2 
    Ambulatory
    (n=40)

    a All patients received 1.33 x 1014 vg/kg, as measured by ddPCR

    b Change from baseline was statistically significant

    c Adjusted for muscle content. Control was level of wild-type (normal) dystrophin in normal muscle.

    Mean change from baseline (SD) 43.4
    (48.6)     		40.7
    (32.3)     		51.0
    (47)
    Median change from baseline
    (Min, Max)     		24.3
    (1.6, 116.3)     		40.8
    (0.0, 92.0)     		46.9
    (1.9, 197.3)

    In Study 3 Part 1, muscle biopsies were obtained at Week 12 in 31 patients. For the ELEVIDYS-treated patients, the mean micro-dystrophin expression at Week 12 was 34.3% (N=17, SD: 41.0%), compared to placebo patients of 0% (N=14, SD: 0%).

    Assessment of micro-dystrophin levels can be meaningfully influenced by differences in sample processing, analytical technique, reference materials, and quantitation methodologies. Therefore, valid comparisons of micro-dystrophin measurements obtained from different assays cannot be made.

    12.3 Pharmacokinetics

    Vector Distribution and Vector Shedding

    Nonclinical Data

    Biodistribution of ELEVIDYS was evaluated in tissue samples collected from healthy mice and DMDmdx mice following intravenous administration in toxicology studies. At 12 weeks following ELEVIDYS administration at dose levels of 1.33 ×1014 to 4.02 ×1014 vg/kg, vector DNA was detected in all major organs with the highest quantities detected in the liver, followed by lower levels in the heart, adrenal glands, skeletal muscle, and aorta. ELEVIDYS was also detected at low levels in the spinal cord, sciatic nerve and gonads (testis). Protein expression of micro-dystrophin was highest in cardiac tissue, exceeding physiologic dystrophin expression levels in healthy mice, with lower levels in the skeletal muscle and diaphragm. In some studies, micro-dystrophin was also detected at low levels in the liver.

    Clinical Data

    Following IV administration, ELEVIDYS vector genome undergoes distribution via systemic circulation and distributes into target muscle tissues followed by elimination in the urine and feces. ELEVIDYS biodistribution and tissue transduction are detected in the target muscle tissue groups and quantified in the gastrocnemius or biceps femoris biopsies obtained from patients with mutations in the DMD gene. Evaluation of ELEVIDYS vector genome exposure in clinical muscle biopsies at Week 12 post-dose expressed as copies per nucleus revealed ELEVIDYS drug distribution and transduction with a mean change from baseline of 2.91 and 3.44 copies per nucleus at the recommended dose of 1.33 × 1014 vg/kg for Study 1 and Study 2 Cohort 1, respectively.

    In Study 2 Cohorts 1-3, the biodistribution and vector shedding of ELEVIDYS in the serum and excreta were quantified, respectively. The mean maximum concentration (Cmax) in the serum was 0.0055 × 1013 copies/mL and 2.78 × 106 copies/mL in the urine, 7.86 × 107 copies/mL in the saliva, and 4.87 × 107 copies/μg in the feces. The median time to achieve maximum concentration (Tmax) was 5.8 hours post-dose in the serum, followed by 6.7 hours, 6.5 hours and 13 days post-dose in the saliva, urine, and feces, respectively. The median time to achieve first below limit of quantification (BLOQ) sample followed by 2 consecutive BLOQ samples was 55 days post-dose for serum. The median time to achieve complete elimination as the first below limit of detection (BLOD) sample followed by 2 consecutive BLOD samples were 49.8 days, 78 days and 162 days post-dose for saliva, urine and feces, respectively. The estimated elimination half-life of ELEVIDYS vector genome in the serum is approximately 12 hours, and the majority of the drug is expected to be cleared from the serum by 1-week post-dose. In the excreta, the estimated elimination half-life of ELEVIDYS vector genome is approximately 40 hours, 55 hours, and 60 hours in the urine, feces, and saliva, respectively. As an AAV-based gene therapy that consists of a protein capsid containing the transgene DNA genome of interest, ELEVIDYS capsid proteins are broken down through proteasomal degradation following AAV entry into target cells. As such, ELEVIDYS is not likely to exhibit the drug-drug interaction potential mediated by known drug metabolizing enzymes (cytochrome P450-based) and drug transporters.

    12.6 Immunogenicity

    The observed incidence of anti-AAVrh74 antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-AAVrh74 antibodies in the studies described below with the incidence of anti-AAVrh74 antibodies in other studies.

    In ELEVIDYS clinical studies, patients were required to have baseline anti-AAVrh74 total binding antibodies of <1:400, measured using an investigational total binding antibody enzyme-linked immunosorbent assay (ELISA), and only patients with baseline anti-AAVrh74 total binding antibodies <1:400 were enrolled in those studies.

    Across clinical studies evaluating a total of 156 patients, elevated anti-AAVrh74 total binding antibodies titers were observed in all patients following a one-time ELEVIDYS infusion. Anti-AAVrh74 total binding antibody titers reached at least 1:3200 in every patient, and the maximum titers exceeded 1:26,214,400 in certain patients. The safety of re-administration of ELEVIDYS or any other AAVrh74 vector-based gene therapy in the presence of high anti-AAVrh74 total binding antibody titer has not been evaluated in humans [see Warnings and Precautions (5.6)].

    There is insufficient data to assess whether the observed anti-AAVrh74 antibodies titers have clinically significant effect on pharmacokinetics, pharmacodynamics, safety, and efficacy of ELEVIDYS.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    No animal studies have been performed to evaluate the effects of ELEVIDYS on carcinogenicity, mutagenesis, or impairment of fertility.

  • 14 CLINICAL STUDIES

    The efficacy of ELEVIDYS was evaluated in two double-blind, placebo-controlled studies (Study 1 [NCT 03769116] and Study 3 [NCT 05096221]) and one open-label study (Study 2 [NCT 04626674]) in which a total of 214 male patients with a confirmed disease-causing mutation in the DMD gene were dosed.

    Study 1

    Study 1 is a completed multi-center study including:

    • Part 1: a 48-week, randomized, double-blind, placebo-controlled period
    • Part 2: a 48-week period that began following completion of Part 1. Patients who received placebo during Part 1 were treated with ELEVIDYS, and patients treated with ELEVIDYS during Part 1 received placebo.

    The study population consisted of male ambulatory DMD patients (N=41) aged 4 through 7 years with either a confirmed frameshift mutation, or a premature stop codon mutation between exons 18 to 58 in the DMD gene.

    Patients were randomized 1:1 to receive either ELEVIDYS (N=20) or placebo (N=21), as a single intravenous infusion via a peripheral limb. Randomization was stratified by age (i.e., aged 4 to 5 years vs. aged 6 to 7 years). In the 4 through 5-year-old subgroup, the mean age, mean weight and mean NSAA total score (range) for the ELEVIDYS-treated patients (n=8) were 4.98 years, 20.1 kg and 20.1 (17-23), and for the placebo patients (n=8) were 5.15 years, 19.8 kg and 20.4 (15-24). In the ELEVIDYS group, eight patients received 1.33 × 1014 vg/kg of ELEVIDYS, and 12 patients received lower doses. Key demographic and baseline characteristics are presented in Table 6.

    Table 6: Key Demographic and Baseline Characteristics (Study 1 Part 1)

    Characteristic    		All
    (n=41)    		ELEVIDYS
    (n=20)    		Placebo
    (n=21)
    Race (%)
    Asian/Black or African American/White/Other     		12/0/73/15 20/0/65/15 5/0/81/14
    Ethnicity (%)
    Hispanic or Latino/
    Other     		12/88 5/95 19/81
    Mean age [range]
    (years)     		6.3
    [4.3 to 7.9]     		6.3
    [4.5 to 7.9]     		6.2
    [4.3 to 7.9]
    Mean weight [range]
    (kg)     		22.4
    [15.0 to 34.5]     		23.3
    [18.0 to 34.5]     		21.6
    [15.0 to 30.0]
    Mean NSAA total score [range] 21.2
    [13 to 29]     		19.8
    [13 to 26]     		22.6
    [15 to 29]
    Mean time to rise from floor [range]
    (seconds)     		4.3
    [2.7 to 10.4]     		5.1
    [3.2 to 10.4]     		3.6
    [2.7 to 4.8]

    All patients were on a stable dose of corticosteroids for DMD for at least 12 weeks prior to ELEVIDYS infusion. All randomized patients had baseline anti-AAVrh74 antibody titers <1:400 as determined by an investigational total binding antibody ELISA.

    One day prior to treatment with ELEVIDYS or placebo, the patient's background dose of corticosteroid for DMD was increased to at least 1 mg/kg of a corticosteroid (prednisone equivalent) daily and was continued at this level for at least 60 days after the infusion, unless earlier tapering was clinically indicated.

    The efficacy outcomes of Study 1 were to evaluate expression of micro-dystrophin in skeletal muscle, and to evaluate the effect of ELEVIDYS on the North Star Ambulatory Assessment (NSAA) total score.

    Results of micro-dystrophin measured by western blot are presented in Table 5 [see Clinical Pharmacology (12.2)].

    The change in NSAA total score was assessed from baseline to Week 48 after infusion of ELEVIDYS or placebo. The difference between the ELEVIDYS and placebo groups was not statistically significant (p=0.37). The least squares (LS) mean changes in NSAA total score from baseline to Week 48 was 1.7 (standard error [SE]: 0.6) points for the ELEVIDYS group and 0.9 (SE: 0.6) points for the placebo group.

    Exploratory subgroup analyses showed that for patients aged 4 through 5 years, the LS mean changes (SE) in NSAA total score from baseline to Week 48 were 4.3 (0.7) points for the ELEVIDYS group, and 1.9 (0.7) points for the placebo group, a numerical advantage for ELEVIDYS. For patients aged 6 through 7 years, the LS mean changes (SE) in NSAA total score from baseline to Week 48 were -0.2 (0.7) points for the ELEVIDYS group and 0.5 (0.7) points for the placebo group, a numerical disadvantage for ELEVIDYS.

    Study 2

    Study 2 is an ongoing, open-label, multi-center study which includes 5 cohorts of 48 male DMD patients.

    Patients in cohorts 1, 2 and 3 have a confirmed frameshift, splice site or premature stop codon mutation anywhere in the DMD gene, while patients in cohort 4 included patients with mutations in the DMD gene starting at or after exon 18. All patients in cohort 5 had mutations that partially or fully overlap with exons 1-17 in the DMD gene. Patients received corticosteroids for DMD before infusion according to Table 1 [see Dosage and Administration (2.2)]. All patients had baseline anti-AAVrh74 antibodies titers ≤1:400 as determined by the investigational total binding antibody ELISA. Patients received a single intravenous infusion of 1.33 × 1014 vg/kg ELEVIDYS if they weighed less than 70 kg or 9.31 × 1015 vg/kg total fixed dose if they weighed 70 kg or greater.

    Cohorts 1, 2, 4 and 5a enrolled 40 ambulatory patients 3 to 12 years of age, with weights ranging from 12.5 to 50.5 kg, baseline mean NSAA total score of 20.3 (11 to 30), and mean time to rise from floor of 4.7 seconds (2.4 to 9.7). Cohorts 3 and 5b include 8 non-ambulatory patients 10 to 20 years of age, with weights ranging from 36.1 to 80.1 kg. Overall key demographics and key baseline characteristics by Cohort are presented in Table 7.

    Table 7: Key Demographic and Baseline Characteristics for Study 2

    a NSAA and Time to rise from floor were not evaluated in non-ambulatory patients


    Characteristics    		All
    (n=48)    		Cohort 1
    (n=20)    		Cohort 2
    (n=7)    		Cohort 3a
    (n=6)    		Cohort 4
    (n=7)    		Cohort 5a
    (n=6)    		Cohort 5ba
    (n=2)
    Race (%)
    Asian/Black or African American/White/Other     		8/6/77/8
    5/5/75/15
    14/0/71/14
    0/0/100/0
    14/0/86/0
    0/33/67/0
    50/0/50/0
    Ethnicity (%)
    Hispanic or Latino/
    Not Hispanic or Latino     		15/85 25/75 14/86 0/100 14/86 0/100 0/100
    Mean age
    [range] (years)     		7.7
    [3.2 to 20.2]     		5.8
    [4.4 to 7.9]     		10.1
    [8.0 to 12.1]     		15.3
    [9.9 to 20.2]     		3.5
    [3.2 to 3.9]     		6.7
    [4.7 to 8.6]     		13.4
    [12.3 to 14.6]
    Mean weight [range] (kg) 30.1
    [12.5 to 80.1]     		21.2
    [15.2 to 33.1]     		37.1
    [28.0 to 50.5]     		59.9
    [36.1 to 80.1]     		15.2
    [12.5 to 16.5]     		32.1
    [19.1 to 47.4]     		51.2
    [43.4 to 59.0]
    Mean NSAA total score [range] 20.3
    [11 to 30]     		22.1
    [18 to 26]     		20.7
    [17 to 26]     		N/A 12.9
    [11 to 17]     		22.5
    [18 to 30]     		N/A
    Mean time to rise from floor [range] (seconds) 4.7
    [2.4 to 9.7]     		4.2
    [2.4 to 8.2]     		5.9
    [3.8 to 9.7]     		N/A 5.2
    [3.8 to 6.7]     		4.6
    [2.5 to 7.7]
    		N/A
    Mean Performance of Upper Limb v. 2.0 score [range] 30.7
    [18 to 42]     		NA 38.9
    [33 to 42]     		22.2
    [18 to 31]     		NA NA 27.5
    [21 to 34]

    The efficacy outcome measure of the study was to evaluate the effect of micro-dystrophin expression as measured by western blot. Results are presented in Table 5 [see Clinical Pharmacology (12.2)].

    Study 3

    Study 3 is a multi-center, randomized, double-blind, placebo-controlled study in which 125 ambulatory male patients aged 4 through 7 years, with a confirmed frameshift, splice site, premature stop codon, or other disease-causing mutation in the DMD gene starting at or after exon 18, were dosed. Patients with exon 45 (inclusive), or in-frame deletions, in-frame duplications, and variants of uncertain significance (“VUS”), were excluded. Patients received corticosteroids for DMD before infusion according to Table 1 [see Dosage and Administration (2.2)]. All patients had baseline anti-AAVrh74 antibodies titers <1:400 as determined by the investigational total binding antibody ELISA and received a single intravenous infusion of 1.33 × 1014 vg/kg ELEVIDYS. Key demographic and baseline characteristics are presented in Table 8.

    The efficacy outcome measure of the study was to evaluate the effect of ELEVIDYS on physical function as assessed by the NSAA total score. Key secondary outcome measures were to evaluate expression of micro-dystrophin in skeletal muscle, time to rise from floor, and time of 10-meter walk/run. Additional efficacy outcome measures included time of 100-meter walk/run, and time to ascend 4 steps. Results of micro-dystrophin measured by western blot are presented in Table 5 [see Clinical Pharmacology (12.2)].

    Table 8: Key Demographic and Baseline Characteristics for Study 3

    Characteristic    		ELEVIDYS
    (n=63)    		Placebo
    (n=62)
    Race (%)
    Asian/Black or African American/ White/Multiple/Other/Not Reported     		13/0/78/2/3/5 18/3/74/0/2/3
    Ethnicity (%)
    Hispanic or Latino/Not Hispanic or Latino/
    Not Reported/Unknown     		24/75/0/2 13/86/2/0
    Mean age
    [range] (years)     		6.0
    [4.1 to 7.9]     		6.1
    [4.0 to 7.9]
    Mean weight
    [range] (kg)     		21.3
    [13.5 to 38.5]     		22.4
    [14.4 to 41.6]
    Mean NSAA total score
    [range]     		23.10
    [14 to 32]     		22.82
    [15.5 to 30]
    Mean time to rise from floor
    [range] (seconds)     		3.52
    [1.9 to 5.8]     		3.60
    [2.3 to 5]
    Mean time of 10-meter walk/run
    [range] (seconds)     		4.82
    [3.2 to 6.9]     		4.92
    [3.7 to 7]
    Mean time of 100-meter walk/run
    [range] (seconds)     		60.67
    [38.0 to 129.2]     		63.01
    [38.7 to 118.1]
    Mean time to ascend 4 steps
    [range] (seconds)     		3.17
    [1.6 to 7.1]     		3.37
    [1.5 to 7.1]

    The change in NSAA total score was assessed from baseline to Week 52 after infusion of ELEVIDYS or placebo. The difference between the ELEVIDYS (n=63) and placebo groups (n=61) was not statistically significant (p=0.24). The least squares (LS) mean changes in NSAA total score from baseline to Week 52 was 2.57 (95% confidence interval [CI]: 1.80, 3.34) points for the ELEVIDYS group and 1.92 (95% CI: 1.14, 2.70) points for the placebo group, with a LS mean difference from placebo of 0.65 (95% CI: -0.45, 1.74). Changes of clinical relevance were noted in three secondary efficacy endpoints, including time to rise from the floor, 10-meter walk/run and time to ascend 4 steps.

    Table 9: Change from Baseline to Week 52 of Timed Function Tests in Study 3 Part 1

    ELEVIDYS
    Placebo    		LS Mean Difference from placebo
    (95% CI)
    Time to rise from the floor (seconds)n=63 n=61 -
    LS mean Change (95% CI) -0.27
    (-0.56, 0.02)     		0.37
    (0.08, 0.67)     		-0.64
    (-1.06, -0.23)
    Time of 10-meter walk/run (seconds)n=63 n=61 -
    LS mean Change (95% CI) -0.34
    (-0.55, -0.14)     		0.08
    (-0.13, 0.29)     		-0.42
    (-0.71, -0.13)
    Time of 100-meter walk/run (seconds)n=59 n=57 -
    LS mean Change (95% CI) -6.57
    (-10.05, -3.09)     		-3.28
    (-6.86, 0.29)     		-3.29
    (-8.28, 1.70)
    Time to ascend 4 steps (seconds)n=62 n=60 -
    LS mean Change (95% CI) -0.44
    (-0.69, -0.20)     		-0.08
    (-0.33, 0.17)     		-0.36
    (-0.71, -0.01)
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    ELEVIDYS is shipped frozen (≤ -60ºC [-76ºF]) in 10 mL vials.

    ELEVIDYS is supplied as a customized kit to meet dosing requirements for each patient [see Dosage and Administration (2.2)]. Each kit contains:

    • Ten (10) to seventy (70) single-dose vials of ELEVIDYS
    • One alcohol wipe per vial

    Each ELEVIDYS pack may contain a maximum of two different drug product lots.

    The total number of vials in each kit corresponds to the dosing requirement for the individual patient, based on the patient's body weight, and is specified on the package [see Dosage and Administration (2.2)]. Each kit includes a specified number of ELEVIDYS vials (with a minimum of 10 vials for a patient with 10.0 – 10.4 kg body weight range, and a maximum of 70 vials for a patient with body weight of 69.5 kg and above).

    Kit sizes and National Drug Codes (NDC) are provided in Table 10.

    Table 10: ELEVIDYS Multi-vial Kits
    Patient Weight
    (kg)    		Total Vials per KitTotal Dose Volume per Kit (mL)NDC Number
    10.0 – 10.4 10 100 60923-501-10
    10.5 – 11.4 11 110 60923-502-11
    11.5 – 12.4 12 120 60923-503-12
    12.5 – 13.4 13 130 60923-504-13
    13.5 – 14.4 14 140 60923-505-14
    14.5 – 15.4 15 150 60923-506-15
    15.5 – 16.4 16 160 60923-507-16
    16.5 – 17.4 17 170 60923-508-17
    17.5 – 18.4 18 180 60923-509-18
    18.5 – 19.4 19 190 60923-510-19
    19.5 – 20.4 20 200 60923-511-20
    20.5 – 21.4 21 210 60923-512-21
    21.5 – 22.4 22 220 60923-513-22
    22.5 – 23.4 23 230 60923-514-23
    23.5 – 24.4 24 240 60923-515-24
    24.5 – 25.4 25 250 60923-516-25
    25.5 – 26.4 26 260 60923-517-26
    26.5 – 27.4 27 270 60923-518-27
    27.5 – 28.4 28 280 60923-519-28
    28.5 – 29.4 29 290 60923-520-29
    29.5 – 30.4 30 300 60923-521-30
    30.5 – 31.4 31 310 60923-522-31
    31.5 – 32.4 32 320 60923-523-32
    32.5 – 33.4 33 330 60923-524-33
    33.5 – 34.4 34 340 60923-525-34
    34.5 – 35.4 35 350 60923-526-35
    35.5 – 36.4 36 360 60923-527-36
    36.5 – 37.4 37 370 60923-528-37
    37.5 – 38.4 38 380 60923-529-38
    38.5 – 39.4 39 390 60923-530-39
    39.5 – 40.4 40 400 60923-531-40
    40.5 – 41.4 41 410 60923-532-41
    41.5 – 42.4 42 420 60923-533-42
    42.5 – 43.4 43 430 60923-534-43
    43.5 – 44.4 44 440 60923-535-44
    44.5 – 45.4 45 450 60923-536-45
    45.5 – 46.4 46 460 60923-537-46
    46.5 – 47.4 47 470 60923-538-47
    47.5 – 48.4 48 480 60923-539-48
    48.5 – 49.4 49 490 60923-540-49
    49.5 – 50.4 50 500 60923-541-50
    50.5 – 51.4 51 510 60923-542-51
    51.5 – 52.4 52 520 60923-543-52
    52.5 – 53.4 53 530 60923-544-53
    53.5 – 54.4 54 540 60923-545-54
    54.5 – 55.4 55 550 60923-546-55
    55.5 – 56.4 56 560 60923-547-56
    56.5 – 57.4 57 570 60923-548-57
    57.5 – 58.4 58 580 60923-549-58
    58.5 – 59.4 59 590 60923-550-59
    59.5 – 60.4 60 600 60923-551-60
    60.5 – 61.4 61 610 60923-552-61
    61.5 – 62.4 62 620 60923-553-62
    62.5 – 63.4 63 630 60923-554-63
    63.5 – 64.4 64 640 60923-555-64
    64.5 – 65.4 65 650 60923-556-65
    65.5 – 66.4 66 660 60923-557-66
    66.5 – 67.4 67 670 60923-558-67
    67.5 – 68.4 68 680 60923-559-68
    68.5 – 69.4 69 690 60923-560-69
    69.5 and above 70 700 60923-561-70

    A 10 mL single-dose vial carton for ELEVIDYS (NDC: 60923-562-01) is not sold individually.

    16.2 Storage and Handling

    • ELEVIDYS is shipped and delivered at ≤ −60ºC [−76ºF].
    • ELEVIDYS can be refrigerated for up to 14 days when stored at 2°C to 8°C (36º F to 46º F) in the upright position.
    • Do not refreeze.
    • Do not shake.
    • Do not place back in the refrigerator once brought to room temperature.
    • Follow local guidelines on handling of biological waste.
  • 17 PATIENT COUNSELING INFORMATION

    Advise the patient to read the FDA-approved Medication Guide.

    Provide a copy of the Medication Guide and review the contents with the patient.

    Inform patients or caregivers that:

    • ELEVIDYS can increase certain liver enzyme levels and cause acute serious liver injury or acute liver failure, and death. Management of acute serious liver injury may require hospitalization. Patients will receive oral corticosteroid medication before and after infusion with ELEVIDYS. Weekly blood tests will be required to monitor liver enzyme levels for 3 months after treatment. Contact a healthcare provider immediately if the patient's skin and/or whites of the eyes appear yellowish, if the patient misses a dose of corticosteroid or vomits it up, or if the patient experiences a change in mental status [see Warnings and Precautions (5.1)].
    • Due to the concomitant administration of corticosteroids, an infection (e.g., cold, flu, gastroenteritis, otitis media, bronchiolitis, pneumonia, etc.) before or after ELEVIDYS infusion could lead to more serious complications, including death. Contact a healthcare provider immediately if symptoms suggestive of infection are observed (e.g., coughing, wheezing, sneezing, runny nose, sore throat, or fever) [see Warnings and Precautions (5.2)].
    • Myocarditis (inflammation of the heart) has been observed within days to more than a year following ELEVIDYS infusion. Weekly monitoring of troponin-I for the first month after treatment is required. Contact a healthcare provider immediately if the patient begins to experience chest pain and/or shortness of breath [see Warnings and Precautions (5.3)].
    • Infusion-related reactions including hypersensitivity and anaphylaxis have occurred during and after ELEVIDYS infusion. Possible symptoms of infusion-related reactions are fast heart rate, fast breathing, swollen lips, being short of breath, nostrils widening, hives, red and blotchy skin, itchy or inflamed lips, rash, vomiting, nausea, chills and fever. Contact a healthcare provider immediately if the patient experiences such a reaction [see Warnings and Precautions (5.4)].
    • Immune-mediated myositis (an immune response affecting muscles) was observed in some patients following ELEVIDYS infusion. Contact a physician immediately if the patient experiences any unexplained increased muscle pain, tenderness, or weakness, including difficulty swallowing, difficulty breathing or difficulty speaking, as these may be symptoms of myositis [see Warnings and Precautions (5.5)].
    • Patient's immunizations should be up to date with current immunization guidelines prior to initiation of the corticosteroid regimen required before ELEVIDYS infusion. Vaccinations should be completed at least 4 weeks prior to initiation of the corticosteroid regimen [see Drug Interactions (7)].
    • Vector shedding of ELEVIDYS occurs primarily through body waste. Practice proper hand hygiene, such as hand washing, when coming into direct contact with patient body waste. Place potentially contaminated materials that may have the patient's bodily fluids/waste in a sealable bag and dispose into regular trash. These precautions should be followed for one month after ELEVIDYS infusion.

    Manufactured for: Sarepta Therapeutics, Inc.
    Cambridge, MA 02142 USA
    U.S. license number 2308

    SAREPTA, SAREPTA THERAPEUTICS and ELEVIDYS are trademarks of Sarepta Therapeutics, Inc.
    ©2025 Sarepta Therapeutics, Inc.

    Elevidys
    delandistrogene
    moxeparvovec-rokl
    suspension for intracenous infusion

  • MEDICATION GUIDE

    This Medication Guide has been approved by the U.S. Food and Drug Administration.           Revised: 11/2025

    MEDICATION GUIDE
    ELEVIDYS (Ah-LEV-ah-dis)
    (delandistrogene moxeparvovec-rokl)
    suspension, for intravenous use

    What is the most important information that you/your child should know about ELEVIDYS?

    1. Rapid serious liver injury and rapid liver failure. ELEVIDYS can increase certain liver lab test levels and cause rapid serious liver injury, rapid liver failure, and death. Complication of blood clots in the blood vessel in the abdomen that helps carry blood from the intestines to the liver has happened. Patients with preexisting liver problems may be at higher risk.
      • You/your child will receive oral corticosteroid medication before and after ELEVIDYS infusion and will need weekly blood tests to monitor liver function for 3 months or longer after treatment.
      • For at least 2 months following ELEVIDYS infusion, stay close to a healthcare facility that your/your child's doctor recommends.
      • Contact your/your child's doctor immediately if your/your child's skin and/or whites of the eyes appear yellowish or if your/your child misses a dose of corticosteroid or vomits it up.
    2. Serious Infection. Because you/your child will be taking corticosteroids as part of ELEVIDYS treatment, this may lower the ability of your/your child's immune system to fight infections and make it easier to get an infection. Getting an infection (like a cold, flu, stomach flu, ear infection, chest infection) before or after ELEVIDYS infusion could lead to more serious health problems, including death. Contact your/your child's doctor right away if you notice any signs of infection such as:
      • coughing
      • wheezing
      • sneezing
      • runny nose
      • sore throat
      • fever
      • Vaccinations should be completed at least 4 weeks before starting the corticosteroids that are part of the ELEVIDYS treatment.
      • ELEVIDYS should not be given if you have/your child has an infection.
    3. Inflammation of the heart muscle (Myocarditis). Serious and life-threatening inflammation of the heart muscle has happened following ELEVIDYS infusion. In individuals who develop inflammation of the heart muscle after receiving ELEVIDYS, they may be at a higher risk of serious complications if they already had a heart condition that has affected how well the heart pumps.

      You/Your child will need weekly blood tests for a heart protein that can detect damage to muscle cells in the heart (troponin-I) for the first month after ELEVIDYS infusion. Contact your/your child's doctor right away if you notice:
      • chest pain
      • trouble breathing or shortness of breath
    4. Infusion-related reactions. Reactions from the infusion, including serious allergic reactions, may happen during or after ELEVIDYS infusion. Contact your/your child's doctor right away if you notice:
      • fast heart rate
      • fast breathing
      • swollen lips
      • shortness of breath
      • nostrils widening
      • hives
      • red and blotchy skin
      • itchy or inflamed lips
      • rash
      • vomiting
      • nausea
      • chills
      • fever
    5. Immune response affecting muscles (Immune-mediated myositis). Immune response affecting muscles, including serious and life-threatening reactions, has happened in patients about 1 month after receiving ELEVIDYS infusion. Contact your/your child's doctor right away if you notice:
      • Unexplained increased muscle pain
      • Tenderness
      • Weakness, including trouble swallowing, breathing or speaking
    See “What are the possible side effects of ELEVIDYS?” for more information about side effects.
    What is ELEVIDYS?
    ELEVIDYS is a prescription gene therapy used to treat ambulatory individuals at least 4 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene.
    ELEVIDYS is not recommended for individuals with:
    • Preexisting liver problems or liver infection because of the high risk of rapid serious liver injury and rapid liver failure
    • Recent vaccination (within 4 weeks of ELEVIDYS treatment)
    • Current or recent infections (within 4 weeks of ELEVIDYS treatment)
    Who should not take ELEVIDYS?
    You/Your child should not receive ELEVIDYS if they have a certain type of genetic mutation, called a deletion, involving any portion of or the entire exon 8 and/or exon 9 in the DMD gene.
    Before taking ELEVIDYS, tell your child's doctor about all your child's medical conditions, including if they have:
    • preexisting liver problems
    • current or recent infection
    • recent vaccinations (within 4 weeks)
    How should your child receive ELEVIDYS?
    • Before receiving ELEVIDYS, you/your child will need to get blood tests to check:
      • the amount of antibodies to ELEVIDYS
      • liver function
      • platelets, which is a kind of blood cell that helps you stop bleeding
      • heart protein
    • Your/Your child's healthcare provider will give ELEVIDYS into a vein of the arm through an intravenous (IV) line that may last around 1 to 2 hours or longer.
    • Your/Your child's healthcare provider will check on you/your child during and at least 3 hours after the infusion for infusion-related reactions. See “What is the most important information I should know about ELEVIDYS?” If an infusion-related reaction occurs during their ELEVIDYS infusion, your/your child's healthcare provider may decide to give ELEVIDYS more slowly or stop the infusion.

    What are the possible side effects of ELEVIDYS?

    • ELEVIDYS can cause serious side effects. See “What is the most important information I should know about ELEVIDYS?”
    • The most common side effects in individuals treated with ELEVIDYS include:
      • vomiting
      • nausea
      • liver injury
      • fever
      • lower number of platelets, which is a kind of blood cell that helps you stop bleeding
      • higher levels of heart protein that can detect damage to muscle cells in the heart (troponin-I)
    Tell your/your child's doctor about any side effects that bother you/your child or that do not go away. These are not all the possible side effects of ELEVIDYS.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    You may also report side effects to Sarepta Therapeutics, Inc. at 1-888-727-3782.
    What should you/your child avoid after receiving ELEVIDYS?
    • Avoid taking new medications that are known to damage the liver as this may make liver problems worse. Tell your doctor about all the medicines you/your child takes, including prescription and over-the counter medicines, vitamins, and herbal supplements.
    • Discuss with your/your child's doctor before receiving a vaccine after ELEVIDYS treatment.
    • Avoid missing any dose of corticosteroids. Contact your/your child's doctor immediately if this happens.
    See “What is the most important information I should know about ELEVIDYS?”
    General information about the safe and effective use of ELEVIDYS.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your/your child's pharmacist or doctor for information about ELEVIDYS that is written for health professionals.
    What are the ingredients in ELEVIDYS?
    Active ingredients: delandistrogene moxeparvovec-rokl
    Inactive ingredients: sodium chloride, tromethamine hydrochloride, tromethamine, magnesium chloride, poloxamer 188

    Manufactured for: Sarepta Therapeutics, Inc. Cambridge, MA 02142 USA U.S. license number 2308
    SAREPTA, SAREPTA THERAPEUTICS and ELEVIDYS are trademarks of Sarepta Therapeutics, Inc.
    ©2025 Sarepta Therapeutics, Inc.
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel –Carton Kit Label

    delandistrogene moxeparvovec-rokl

    ELEVIDYS

    1.33 x 1013 vector genomes/mL

    Suspension for Infusion

    For Intravenous Use

    See enclosed prescribing information for dosage
    and administration instructions.

    Preservative-free

    Discard unused
    portion

    Single patient use

    Store unopened vials at ≤-60°C (-76°F) in
    original carton.

    Unopened vials can be refrigerated for up to

    14 days at 2°C to 8°C (36°F to 46°F).

    DO NOT REFREEZE

    DO NOT SHAKE

    Rx Only

    Manufactured for Sarepta Therapeutics, Inc.,
    Cambridge, MA 02142 USA

    US License No. 2308

    SAREPTA

    THERAPEUTICS

    Principal Display Panel –Carton Kit Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 10 count Carton Label

    NDC: 60923-501-10

    delandistrogene
    moxeparvovec-rokl

    ELEVIDYS

    Patient Weight:

    10.0 - 10.4 kg

    Kit Contents:

    10 x 10 mL vials

    10 alcohol swabs

    Principal Display Panel -10 mL 10 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 11 count Carton Label

    NDC: 60923-502-11

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    10.5 - 11.4 kg

    Kit Contents:

    11 x 10 mL vials

    11 alcohol swabs

    Principal Display Panel -10 mL 11 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 12 count Carton Label

    NDC: 60923-503-12

    delandistrogene
    moxeparvovec-rokl

    ELEVIDYS

    Patient Weight:

    11.5 - 12.4 kg

    Kit Contents:

    12 x 10 mL vials

    12 alcohol swabs

    Principal Display Panel -10 mL 12 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 13 count Carton Label

    NDC: 60923-504-13

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    12.5 - 13.4 kg

    Kit Contents:

    13 x 10 mL vials

    13 alcohol swabs

    Principal Display Panel -10 mL 13 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 14 count Carton Label

    NDC: 60923-505-14

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    13.5 - 14.4 kg

    Kit Contents:

    14 x 10 mL vials

    14 alcohol swabs

    Principal Display Panel -10 mL 14 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 15 count Carton Label

    NDC: 60923-506-15

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    14.5 - 15.4 kg

    Kit Contents:

    15 x 10 mL vials

    15 alcohol swabs

    Principal Display Panel -10 mL 15 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 16 count Carton Label

    NDC: 60923-507-16

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    15.5 - 16.4 kg

    Kit Contents:

    16 x 10 mL vials

    16 alcohol swabs

    Principal Display Panel -10 mL 16 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 17 count Carton Label

    NDC: 60923-508-17

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    16.5 - 17.4 kg

    Kit Contents:

    17 x 10 mL vials

    17 alcohol swabs

    Principal Display Panel -10 mL 17 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 18 count Carton Label

    NDC: 60923-509-18

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    17.5 - 18.4 kg

    Kit Contents:

    18 x 10 mL vials

    18 alcohol swabs

    Principal Display Panel -10 mL 18 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 19 count Carton Label

    NDC: 60923-510-19

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    18.5 - 19.4 kg

    Kit Contents:

    19 x 10 mL vials

    19 alcohol swabs

    Principal Display Panel -10 mL 19 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 20 count Carton Label

    NDC: 60923-511-20

    delandistrogene
    moxeparvovec-rokl

    ELEVIDYS

    Patient Weight:

    19.5 - 20.4 kg

    Kit Contents:

    20 x 10 mL vials

    20 alcohol swabs

    Principal Display Panel -10 mL 20 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 21 count Carton Label

    NDC: 60923-512-21

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    20.5 - 21.4 kg

    Kit Contents:

    21 x 10 mL vials

    21 alcohol swabs

    Principal Display Panel -10 mL 21 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 22 count Carton Label

    NDC: 60923-513-22

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    21.5 - 22.4 kg

    Kit Contents:

    22 x 10 mL vials

    22 alcohol swabs

    Principal Display Panel -10 mL 22 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 23 count Carton Label

    NDC: 60923-514-23

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    22.5 - 23.4 kg

    Kit Contents:

    23 x 10 mL vials

    23 alcohol swabs

    Principal Display Panel -10 mL 23 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 24 count Carton Label

    NDC: 60923-515-24

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    23.5 - 24.4 kg

    Kit Contents:

    24 x 10 mL vials

    24 alcohol swabs

    Principal Display Panel -10 mL 24 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 25 count Carton Label

    NDC: 60923-516-25

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    24.5 - 25.4 kg

    Kit Contents:

    25 x 10 mL vials

    25 alcohol swabs

    Principal Display Panel -10 mL 25 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 26 count Carton Label

    NDC: 60923-517-26

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    25.5 - 26.4 kg

    Kit Contents:

    26 x 10 mL vials

    26 alcohol swabs

    Principal Display Panel -10 mL 26 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 27 count Carton Label

    NDC: 60923-518-27

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    26.5 - 27.4 kg

    Kit Contents:

    27 x 10 mL vials

    27 alcohol swabs

    Principal Display Panel -10 mL 27 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 28 count Carton Label

    NDC: 60923-519-28

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    27.5 - 28.4 kg

    Kit Contents:

    28 x 10 mL vials

    28 alcohol swabs

    Principal Display Panel -10 mL 28 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 29 count Carton Label

    NDC: 60923-520-29

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    28.5 - 29.4 kg

    Kit Contents:

    29 x 10 mL vials

    29 alcohol swabs

    Principal Display Panel -10 mL 29 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 30 count Carton Label

    NDC: 60923-521-30

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    29.5 - 30.4 kg

    Kit Contents:

    30 x 10 mL vials

    30 alcohol swabs

    Principal Display Panel -10 mL 30 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 31 count Carton Label

    NDC: 60923-522-31

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    30.5 - 31.4 kg

    Kit Contents:

    31 x 10 mL vials

    31 alcohol swabs

    Principal Display Panel -10 mL 31 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 32 count Carton Label

    NDC: 60923-523-32

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    31.5 - 32.4 kg

    Kit Contents:

    32 x 10 mL vials

    32 alcohol swabs

    Principal Display Panel -10 mL 32 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 33 count Carton Label

    NDC: 60923-524-33

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    32.5 - 33.4 kg

    Kit Contents:

    33 x 10 mL vials

    33 alcohol swabs

    Principal Display Panel -10 mL 33 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 34 count Carton Label

    NDC: 60923-525-34

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    33.5 - 34.4 kg

    Kit Contents:

    34 x 10 mL vials

    34 alcohol swabs

    Principal Display Panel -10 mL 34 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 35 count Carton Label

    NDC: 60923-526-35

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    34.5 - 35.4 kg

    Kit Contents:

    35 x 10 mL vials

    35 alcohol swabs

    Principal Display Panel -10 mL 35 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 36 count Carton Label

    NDC: 60923-527-36

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    35.5 - 36.4 kg

    Kit Contents:

    36 x 10 mL vials

    36 alcohol swabs

    Principal Display Panel -10 mL 36 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 37 count Carton Label

    NDC: 60923-528-37

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    36.5 - 37.4 kg

    Kit Contents:

    37 x 10 mL vials

    37 alcohol swabs

    Principal Display Panel -10 mL 37 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 38 count Carton Label

    NDC: 60923-529-38

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    37.5 - 38.4 kg

    Kit Contents:

    38 x 10 mL vials

    38 alcohol swabs

    Principal Display Panel -10 mL 38 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 39 count Carton Label

    NDC: 60923-530-39

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    38.5 - 39.4 kg

    Kit Contents:

    39 x 10 mL vials

    39 alcohol swabs

    Principal Display Panel -10 mL 39 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 40 count Carton Label

    NDC: 60923-531-40

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    39.5 - 40.4 kg

    Kit Contents:

    40 x 10 mL vials

    40 alcohol swabs

    Principal Display Panel -10 mL 40 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 41 count Carton Label

    NDC: 60923-532-41

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    40.5 - 41.4 kg

    Kit Contents:

    41 x 10 mL vials

    41 alcohol swabs

    Principal Display Panel -10 mL 41 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 42 count Carton Label

    NDC: 60923-533-42

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    41.5 - 42.4 kg

    Kit Contents:

    42 x 10 mL vials

    42 alcohol swabs

    Principal Display Panel -10 mL 42 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 43 count Carton Label

    NDC: 60923-534-43

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    42.5 - 43.4 kg

    Kit Contents:

    43 x 10 mL vials

    43 alcohol swabs

    Principal Display Panel -10 mL 43 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 44 count Carton Label

    NDC: 60923-535-44

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    43.5 - 44.4 kg

    Kit Contents:

    44 x 10 mL vials

    44 alcohol swabs

    Principal Display Panel -10 mL 44 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 45 count Carton Label

    NDC: 60923-536-45

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    44.5 - 45.4 kg

    Kit Contents:

    45 x 10 mL vials

    45 alcohol swabs

    Principal Display Panel -10 mL 45 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 46 count Carton Label

    NDC: 60923-537-46

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    45.5 - 46.4 kg

    Kit Contents:

    46 x 10 mL vials

    46 alcohol swabs

    Principal Display Panel -10 mL 46 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 47 count Carton Label

    NDC: 60923-538-47

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    46.5 - 47.4 kg

    Kit Contents:

    47 x 10 mL vials

    47 alcohol swabs

    Principal Display Panel -10 mL 47 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 48 count Carton Label

    NDC: 60923-539-48

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    47.5 - 48.4 kg

    Kit Contents:

    48 x 10 mL vials

    48 alcohol swabs

    Principal Display Panel -10 mL 48 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 49 count Carton Label

    NDC: 60923-540-49

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    48.5 - 49.4 kg

    Kit Contents:

    49 x 10 mL vials

    49 alcohol swabs

    Principal Display Panel -10 mL 49 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 50 count Carton Label

    NDC: 60923-541-50

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    49.5 - 50.4 kg

    Kit Contents:

    50 x 10 mL vials

    50 alcohol swabs

    Principal Display Panel -10 mL 50 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel –Carton Kit Label

    delandistrogene moxeparvovec-rokl

    ELEVIDYS

    1.33 x 1013 vector genomes/mL

    Suspension for Infusion

    For Intravenous Use

    See enclosed prescribing information for dosage
    and administration instructions.

    Preservative-free

    Discard unused
    portion

    Single patient use

    Store unopened vials at ≤-60°C (-76°F) in
    original carton.

    Unopened vials can be refrigerated for up to

    14 days at 2°C to 8°C (36°F to 46°F).

    DO NOT REFREEZE

    DO NOT SHAKE

    Rx Only

    Manufactured for Sarepta Therapeutics, Inc.,
    Cambridge, MA 02142 USA

    US License No. 2308

    Principal Display Panel –Carton Kit Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel –Carton Kit Label

    delandistrogene moxeparvovec-rokl

    ELEVIDYS

    1.33 x 1013 vector genomes/mL

    Suspension for Infusion

    For Intravenous Use

    See enclosed prescribing information for dosage
    and administration instructions.

    Preservative-free

    Discard unused
    portion

    Single patient use

    Store unopened vials at ≤-60°C (-76°F) in
    original carton.

    Unopened vials can be refrigerated for up to

    14 days at 2°C to 8°C (36°F to 46°F).

    DO NOT REFREEZE

    DO NOT SHAKE

    Rx Only

    Manufactured for Sarepta Therapeutics, Inc.,
    Cambridge, MA 02142 USA

    US License No. 2308

    Principal Display Panel –Carton Kit Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel –Vial Label

    delandistrogene moxeparvovec-rokl

    ELEVIDYS

    1.33 x 1013 vector genomes/mL

    Suspension for infusion. Single-dose vial 10 mL.
    For intravenous use. Store at ≤ -60°C (-76°F).

    Do not refreeze. Do not shake.

    Mfg. for: Sarepta Therapeutics, Inc.,
    Cambridge, MA 02142 USA
    US License No. 2308

    Rx Only

    NDC: 60923-562-01

    Principal Display Panel –Vial Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 51 count Carton Label

    NDC: 60923-542-51

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    50.5 - 51.4 kg

    Kit Contents:

    51 x 10 mL vials

    51 alcohol swabs

    Principal Display Panel -10 mL 51 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 52 count Carton Label

    NDC: 60923-543-52

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    51.5 - 52.4 kg

    Kit Contents:

    52 x 10 mL vials

    52 alcohol swabs

    Principal Display Panel -10 mL 52 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 53 count Carton Label

    NDC: 60923-544-53

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    52.5 - 53.4 kg

    Kit Contents:

    53 x 10 mL vials

    53 alcohol swabs

    Principal Display Panel -10 mL 53 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 54 count Carton Label

    NDC: 60923-545-54

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    53.5 - 54.4 kg

    Kit Contents:

    54 x 10 mL vials

    54 alcohol swabs

    Principal Display Panel -10 mL 54 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 55 count Carton Label

    NDC: 60923-546-55

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    54.5 - 55.4 kg

    Kit Contents:

    55 x 10 mL vials

    55 alcohol swabs

    Principal Display Panel -10 mL 55 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 56 count Carton Label

    NDC: 60923-547-56

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    55.5 - 56.4 kg

    Kit Contents:

    56 x 10 mL vials

    56 alcohol swabs

    Principal Display Panel -10 mL 56 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 57 count Carton Label

    NDC: 60923-548-57

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    56.5 - 57.4 kg

    Kit Contents:

    57 x 10 mL vials

    57 alcohol swabs

    Principal Display Panel -10 mL 57 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 58 count Carton Label

    NDC: 60923-549-58

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    57.5 - 58.4 kg

    Kit Contents:

    58 x 10 mL vials

    58 alcohol swabs

    Principal Display Panel -10 mL 58 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 59 count Carton Label

    NDC: 60923-550-59

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    58.5 - 59.4 kg

    Kit Contents:

    59 x 10 mL vials

    59 alcohol swabs

    Principal Display Panel -10 mL 59 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 60 count Carton Label

    NDC: 60923-551-60

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    59.5 - 60.4 kg

    Kit Contents:

    60 x 10 mL vials

    60 alcohol swabs

    Principal Display Panel -10 mL 60 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 61 count Carton Label

    NDC: 60923-552-61

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    60.5 - 61.4 kg

    Kit Contents:

    61 x 10 mL vials

    61 alcohol swabs

    Principal Display Panel -10 mL 61 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 62 count Carton Label

    NDC: 60923-553-62

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    61.5 - 62.4 kg

    Kit Contents:

    62 x 10 mL vials

    62 alcohol swabs

    Principal Display Panel -10 mL 62 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 63 count Carton Label

    NDC: 60923-554-63

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    62.5 - 63.4 kg

    Kit Contents:

    63 x 10 mL vials

    63 alcohol swabs

    Principal Display Panel -10 mL 63 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 64 count Carton Label

    NDC: 60923-555-64

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    63.5 - 64.4 kg

    Kit Contents:

    64 x 10 mL vials

    64 alcohol swabs

    Principal Display Panel -10 mL 64 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 65 count Carton Label

    NDC: 60923-556-65

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    64.5 - 65.4 kg

    Kit Contents:

    65 x 10 mL vials

    65 alcohol swabs

    Principal Display Panel -10 mL 65 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 66 count Carton Label

    NDC: 60923-557-66

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    65.5 - 66.4 kg

    Kit Contents:

    66 x 10 mL vials

    66 alcohol swabs

    Principal Display Panel -10 mL 66 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 67 count Carton Label

    NDC: 60923-558-67

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    66.5 - 67.4 kg

    Kit Contents:

    67 x 10 mL vials

    67 alcohol swabs

    Principal Display Panel -10 mL 67 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 68 count Carton Label

    NDC: 60923-559-68

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    67.5 - 68.4 kg

    Kit Contents:

    68 x 10 mL vials

    68 alcohol swabs

    Principal Display Panel -10 mL 68 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 69 count Carton Label

    NDC: 60923-560-69

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    68.5 - 69.4 kg

    Kit Contents:

    69 x 10 mL vials

    69 alcohol swabs

    Principal Display Panel -10 mL 69 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel -10 mL 70 count Carton Label

    NDC: 60923-561-70

    delandistrogene
    moxeparvovec-rokl
    ELEVIDYS

    Patient Weight:

    69.5 kg and
    above

    Kit Contents:

    70 x 10 mL vials

    70 alcohol swabs

    Principal Display Panel -10 mL 70 count Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 10 mL Vial Label

    NDC: 60923-562-01

    delandistrogene moxeparvovec-rokl

    ELEVIDYS

    1.33 x 1013 vector genomes/mL

    Suspension for Infusion

    For Intravenous Use

    See enclosed prescribing information
    for dosage and administration instructions.

    Rx Only

    Single-dose

    1 vial

    Principal Display Panel – 10 mL Vial Label
  • INGREDIENTS AND APPEARANCE
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-501-101 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 VIAL, SINGLE-USE 100 mL
    Part 210 POUCH 10 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-502-111 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 111 VIAL, SINGLE-USE 110 mL
    Part 211 POUCH 11 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    111 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-503
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-503-121 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 112 VIAL, SINGLE-USE 120 mL
    Part 212 POUCH 12 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-504
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-504-131 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 113 VIAL, SINGLE-USE 130 mL
    Part 213 POUCH 13 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    113 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-505
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-505-141 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 114 VIAL, SINGLE-USE 140 mL
    Part 214 POUCH 14 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-506
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-506-151 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 115 VIAL, SINGLE-USE 150 mL
    Part 215 POUCH 15 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-507
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-507-161 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 116 VIAL, SINGLE-USE 160 mL
    Part 216 POUCH 16 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-508
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-508-171 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 117 VIAL, SINGLE-USE 170 mL
    Part 217 POUCH 17 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    117 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-509
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-509-181 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 118 VIAL, SINGLE-USE 180 mL
    Part 218 POUCH 18 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    118 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-510
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-510-191 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 119 VIAL, SINGLE-USE 190 mL
    Part 219 POUCH 19 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    119 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-511
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-511-201 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 VIAL, SINGLE-USE 200 mL
    Part 220 POUCH 20 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    120 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-512
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-512-211 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 121 VIAL, SINGLE-USE 210 mL
    Part 221 POUCH 21 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    121 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-513
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-513-221 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 122 VIAL, SINGLE-USE 220 mL
    Part 222 POUCH 22 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    122 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-514
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-514-231 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 123 VIAL, SINGLE-USE 230 mL
    Part 223 POUCH 23 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    123 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-515
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-515-241 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 124 VIAL, SINGLE-USE 240 mL
    Part 224 POUCH 24 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    124 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-516
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-516-251 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 125 VIAL, SINGLE-USE 250 mL
    Part 225 POUCH 25 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    125 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-517
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-517-261 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 126 VIAL, SINGLE-USE 260 mL
    Part 226 POUCH 26 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    126 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-518
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-518-271 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 127 VIAL, SINGLE-USE 270 mL
    Part 227 POUCH 27 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    127 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-519
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-519-281 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 128 VIAL, SINGLE-USE 280 mL
    Part 228 POUCH 28 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-520
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-520-291 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 129 VIAL, SINGLE-USE 290 mL
    Part 229 POUCH 29 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    129 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-521
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-521-301 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 130 VIAL, SINGLE-USE 300 mL
    Part 230 POUCH 30 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-522
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-522-311 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 131 VIAL, SINGLE-USE 310 mL
    Part 231 POUCH 31 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    131 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-523
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-523-321 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 132 VIAL, SINGLE-USE 320 mL
    Part 232 POUCH 32 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    132 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-524
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-524-331 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 133 VIAL, SINGLE-USE 330 mL
    Part 233 POUCH 33 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    133 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-525
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-525-341 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 134 VIAL, SINGLE-USE 340 mL
    Part 234 POUCH 34 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    134 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-526
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-526-351 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 135 VIAL, SINGLE-USE 350 mL
    Part 235 POUCH 35 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    135 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-527
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-527-361 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 136 VIAL, SINGLE-USE 360 mL
    Part 236 POUCH 36 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    136 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-528
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-528-371 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 137 VIAL, SINGLE-USE 370 mL
    Part 237 POUCH 37 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    137 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-529
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-529-381 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 138 VIAL, SINGLE-USE 380 mL
    Part 238 POUCH 38 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    138 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-530
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-530-391 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 139 VIAL, SINGLE-USE 390 mL
    Part 239 POUCH 39 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    139 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-531
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-531-401 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 140 VIAL, SINGLE-USE 400 mL
    Part 240 POUCH 40 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    140 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-532
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-532-411 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 141 VIAL, SINGLE-USE 410 mL
    Part 241 POUCH 41 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    141 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-533
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-533-421 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 142 VIAL, SINGLE-USE 420 mL
    Part 242 POUCH 42 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    142 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-534
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-534-431 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 143 VIAL, SINGLE-USE 430 mL
    Part 243 POUCH 43 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    143 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-535
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-535-441 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 144 VIAL, SINGLE-USE 440 mL
    Part 244 POUCH 44 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    144 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-536
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-536-451 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 145 VIAL, SINGLE-USE 450 mL
    Part 245 POUCH 45 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    145 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-537
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-537-461 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 146 VIAL, SINGLE-USE 460 mL
    Part 246 POUCH 46 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    146 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-538
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-538-471 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 147 VIAL, SINGLE-USE 470 mL
    Part 247 POUCH 47 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    147 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-539
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-539-481 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 148 VIAL, SINGLE-USE 480 mL
    Part 248 POUCH 48 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    148 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-540
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-540-491 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 149 VIAL, SINGLE-USE 490 mL
    Part 249 POUCH 49 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    149 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-541
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-541-501 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 150 VIAL, SINGLE-USE 500 mL
    Part 250 POUCH 50 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-542
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-542-511 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 151 VIAL, SINGLE-USE 510 mL
    Part 251 POUCH 51 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    151 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-543
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-543-521 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 152 VIAL, SINGLE-USE 520 mL
    Part 252 POUCH 52 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    152 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-544
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-544-531 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 153 VIAL, SINGLE-USE 530 mL
    Part 253 POUCH 53 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    153 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-545
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-545-541 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 154 VIAL, SINGLE-USE 540 mL
    Part 254 POUCH 54 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    154 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-546
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-546-551 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 155 VIAL, SINGLE-USE 550 mL
    Part 255 POUCH 55 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    155 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-547
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-547-561 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 156 VIAL, SINGLE-USE 560 mL
    Part 256 POUCH 56 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    156 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-548
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-548-571 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 157 VIAL, SINGLE-USE 570 mL
    Part 257 POUCH 57 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    157 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-549
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-549-581 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 158 VIAL, SINGLE-USE 580 mL
    Part 258 POUCH 58 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    158 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-550
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-550-591 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 159 VIAL, SINGLE-USE 590 mL
    Part 259 POUCH 59 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-551
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-551-601 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 160 VIAL, SINGLE-USE 600 mL
    Part 260 POUCH 60 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-552
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-552-611 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 161 VIAL, SINGLE-USE 610 mL
    Part 261 POUCH 61 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    161 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-553
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-553-621 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 162 VIAL, SINGLE-USE 620 mL
    Part 262 POUCH 62 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    162 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-554
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-554-631 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 163 VIAL, SINGLE-USE 630 mL
    Part 263 POUCH 63 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    163 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-555
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-555-641 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 164 VIAL, SINGLE-USE 640 mL
    Part 264 POUCH 64 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    164 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-556
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-556-651 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 165 VIAL, SINGLE-USE 650 mL
    Part 265 POUCH 65 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-557
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-557-661 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 166 VIAL, SINGLE-USE 660 mL
    Part 266 POUCH 66 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    166 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-558
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-558-671 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 167 VIAL, SINGLE-USE 670 mL
    Part 267 POUCH 67 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    167 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-559
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-559-681 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 168 VIAL, SINGLE-USE 680 mL
    Part 268 POUCH 68 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    168 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-560
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-560-691 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 169 VIAL, SINGLE-USE 690 mL
    Part 269 POUCH 69 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    169 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60923-561
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-561-701 in 1 CARTON; Type 0: Not a Combination Product06/22/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 170 VIAL, SINGLE-USE 700 mL
    Part 270 POUCH 70 
    Part 1 of 2
    ELEVIDYS 
    delandistrogene moxeparvovec-rokl injection, suspension
    Product Information
    Item Code (Source)NDC: 60923-562
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    delandistrogene moxeparvovec (UNII: 2P6QV2ZE52) (delandistrogene moxeparvovec - UNII:2P6QV2ZE52) delandistrogene moxeparvovec13300000000000 {GC}  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium chloride (UNII: 451W47IQ8X)  
    Tromethamine Hydrochloride (UNII: 383V75M34E)  
    Tromethamine (UNII: 023C2WHX2V)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 60923-562-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Part 2 of 2
    ISOPROPYL ALCOHOL SWABS 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC: 60923-563
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol0.75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    170 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12578106/22/2023
    Labeler - Sarepta Therapeutics, Inc. (121653406)

    • Trademark Results [ELEVIDYS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ELEVIDYS
    ELEVIDYS
    97925396 not registered Live/Pending
    Sarepta Therapeutics, Inc.
    2023-05-08
    ELEVIDYS
    ELEVIDYS
    97923896 not registered Live/Pending
    Sarepta Therapeutics, Inc.
    2023-05-06
    ELEVIDYS
    ELEVIDYS
    88886693 not registered Live/Pending
    Sarepta Therapeutics, Inc.
    2020-04-24
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