FDA.reportPublic FDA data

Trikafta

Product NDC
51167-445
11-digit product format
511670445
Labeler code
51167
Product ID
51167-445_d16848f4-2958-44c0-b688-8a9b25d9032f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Elexacaftor, Tezacaftor, and Ivacaftor
Dosage form
KIT
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA217660
Marketing category
NDA
Marketing start
2023-04-26
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217660-001TRIKAFTA (COPACKAGED)ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR80MG, 60MG, 40MG;59.5MGGRANULE / ORALRLD2023-04-26
N217660-002TRIKAFTA (COPACKAGED)ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR100MG, 75MG, 50MG;75MGGRANULE / ORALRLD, RS2023-04-26

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217660-00183544272026-07-06U-35932023-05-24
N217660-00184102742026-12-28Drug product2023-05-24
N217660-00187542242026-12-28Drug substance, Drug product2023-05-24
N217660-00196701632026-12-28U-4068Drug product2023-05-24
N217660-00196701632026-12-28U-3591Drug product2023-05-24
N217660-00196701632026-12-28U-4478Drug product2023-05-24
N217660-00199313342026-12-28U-4478Drug product2023-05-24
N217660-00199313342026-12-28U-3591Drug product2023-05-24
N217660-00199313342026-12-28U-4068Drug product2023-05-24
N217660-001100223522027-04-09U-3596Drug product2023-05-24
N217660-001102398672027-04-09U-4476Drug substance, Drug product2023-05-24
N217660-001102398672027-04-09U-3590Drug substance, Drug product2023-05-24
N217660-001102398672027-04-09U-4053Drug substance, Drug product2023-05-24
N217660-001116393472027-04-09U-4053Drug substance, Drug product2023-05-24
N217660-001116393472027-04-09U-3583Drug substance, Drug product2023-05-24
N217660-001116393472027-04-09U-4476Drug substance, Drug product2023-05-24
N217660-00199747812027-04-09U-4476Drug product2023-05-24
N217660-00199747812027-04-09U-4066Drug product2023-05-24
N217660-00199747812027-04-09U-3589Drug product2023-05-24
N217660-00176457892027-05-01Drug substance, Drug product2023-05-24
N217660-00185981812027-05-01U-44762023-05-24
N217660-00185981812027-05-01U-40662023-05-24
N217660-00185981812027-05-01U-35892023-05-24
N217660-00186239052027-05-01Drug substance, Drug product2023-05-24
N217660-00174951032027-05-20Drug substance, Drug product2023-05-24
N217660-00177769052027-06-03Drug substance, Drug product2023-05-24
N217660-00183242422027-08-05U-40662023-05-24
N217660-00183242422027-08-05U-35892023-05-24
N217660-00183242422027-08-05U-44762023-05-24
N217660-00184153872027-11-12U-40662023-05-24
N217660-00184153872027-11-12U-35892023-05-24
N217660-00184153872027-11-12U-44762023-05-24
N217660-001106464812029-08-13Drug product2023-05-24
N217660-001115649162029-08-13U-44852023-05-24
N217660-001115649162029-08-13U-40552023-05-24
N217660-001115649162029-08-13U-35852023-05-24
N217660-001124586352029-08-13U-4333Drug product2025-11-21
N217660-001124586352029-08-13U-4493Drug product2025-11-21
N217660-001100816212031-03-25U-3600Drug product2023-05-24
N217660-001100816212031-03-25U-4481Drug product2023-05-24
N217660-001100816212031-03-25U-4065Drug product2023-05-24
N217660-001115780622031-03-25U-4488Drug product2023-05-24
N217660-001115780622031-03-25U-4054Drug product2023-05-24
N217660-001115780622031-03-25U-3584Drug product2023-05-24
N217660-001RE504532031-07-10Drug substance, Drug product2025-07-11
N217660-001102720462033-02-27U-4062Drug product2023-05-24
N217660-001102720462033-02-27U-4482Drug product2023-05-24
N217660-001102720462033-02-27U-3599Drug product2023-05-24
N217660-001111477702033-02-27U-4060Drug product2023-05-24
N217660-001111477702033-02-27U-3598Drug product2023-05-24
N217660-001111477702033-02-27U-4483Drug product2023-05-24
N217660-001117521062033-02-27U-4489Drug product2023-10-11
N217660-001117521062033-02-27U-4052Drug product2023-10-11
N217660-001117521062033-02-27U-3696Drug product2023-10-11
N217660-001122140832033-02-27U-4492Drug product2025-03-03
N217660-001122140832033-02-27U-4141Drug product2025-03-03
N217660-00188832062033-02-27Drug product2023-05-24
N217660-001107585342035-10-06U-3589Drug substance, Drug product2023-05-24
N217660-001107585342035-10-06U-4066Drug substance, Drug product2023-05-24
N217660-001107585342035-10-06U-4476Drug substance, Drug product2023-05-24
N217660-001114264072035-10-06U-4476Drug substance, Drug product2023-05-24
N217660-001114264072035-10-06U-3595Drug substance, Drug product2023-05-24
N217660-001114264072035-10-06U-4058Drug substance, Drug product2023-05-24
N217660-001107935472037-12-08U-3588Drug substance, Drug product2023-05-24
N217660-001107935472037-12-08U-4476Drug substance, Drug product2023-05-24
N217660-001107935472037-12-08U-4066Drug substance, Drug product2023-05-24
N217660-001111793672037-12-08U-4484Drug product2023-05-24
N217660-001111793672037-12-08U-4059Drug product2023-05-24
N217660-001111793672037-12-08U-3597Drug product2023-05-24
N217660-001114536552037-12-08Drug substance, Drug product2023-05-24
N217660-001115175642037-12-08U-3586Drug product2023-05-24
N217660-001115175642037-12-08U-4057Drug product2023-05-24
N217660-001115175642037-12-08U-4476Drug product2023-05-24
N217660-00283544272026-07-06U-35932023-05-24
N217660-00284102742026-12-28Drug product2023-05-24
N217660-00287542242026-12-28Drug substance, Drug product2023-05-24
N217660-00296701632026-12-28U-3591Drug product2023-05-24
N217660-00296701632026-12-28U-4478Drug product2023-05-24
N217660-00296701632026-12-28U-4068Drug product2023-05-24
N217660-00299313342026-12-28U-4068Drug product2023-05-24

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217660-001NP2026-04-26
N217660-001M-3132027-12-20
N217660-001ODE-4332030-04-26
N217660-001ODE-5122031-12-20
N217660-001ODE-5432033-03-27
N217660-002NP2026-04-26
N217660-002ODE-4332030-04-26
N217660-002ODE-5122031-12-20
N217660-002ODE-5432033-03-27

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrikaftaELEXACAFTOR, TEZACAFTOR, AND IVACAFTORVertex Pharmaceuticals Incorporatedf354423a-85c2-41c3-a9db-0f3aee135d8d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA, in both clinical trials and the postmarketing setting [see Adverse Reactions (6) ]. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA . Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA. Assess liver function tests every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test elevations at baseline [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Adverse Reactions (6) and Use in Specific Populations (8.7) ] . Interrupt TRIKAFTA for significant elevations in liver function tests or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If abnormalities resolve, resume treatment only if the benefit is expected to outweigh the risk. Closer monitoring is advised after resuming TRIKAFTA [see Warnings and Precautions (5.1) ] . TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). If used, use with caution at a reduced dosage and monitor patients closely [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) , Adverse Reactions (6) , Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE See full prescribing information for complete boxed warning. TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Liver failure leading to transplantation and death has been reported. ( 5.1 , 6 ) Assess liver function tests (ALT, AST, alkaline phosphatase, bilirubin) in all patients prior to initiating TRIKAFTA. ( 2.1 , 5.1 ) Monitor liver function tests (ALT, AST, alkaline phosphatase, bilirubin) every month for the...

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Drug-induced liver injury and liver failure : TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Assess liver function tests (ALT, AST, alkaline phosphatase, bilirubin) in all patients prior to initiating and throughout treatment with TRIKAFTA. Interrupt TRIKAFTA in the event of significant elevations in liver function tests or signs or symptoms of liver injury. TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.1 , 2.3 , 5.1 , 6 , 8.7 , 12.3 ) Hypersensitivity reactions : Angioedema and anaphylaxis have been reported with TRIKAFTA in the postmarketing setting. Initiate appropriate therapy in the event of a hypersensitivity reaction. ( 5.2 ) Intracranial hypertension : Intracranial hypertension (IH) has been reported in the postmarketing setting with the use of TRIKAFTA. If an unusual headache or visual disturbances occur during treatment, and IH is suspected, interrupt TRIKAFTA and refer for prompt medical evaluation. ( 5.3 ) Neuropsychiatric events, including suicidal thoughts and behaviors : Serious neuropsychiatric events, including symptoms of anxiety, depression, suicidal ideation and behavior, and sleep disturbances, have been reported in the postmarketing setting for TRIKAFTA or drugs containing the same or similar active ingredients. Monitor patients closely for new or worsening symptoms. Consider the risks and benefits for the individual patient to determine if therapy with TRIKAFTA should be interrupted at the occurrence of neuropsychiatric symptoms. ( 5.4 ) Use with CYP3A inducers : Concomitant use with strong CYP3A inducers (e.g., rifampin, St. John's wort) significantly decrease ivacaftor exposure and are expected to decrease elexacaftor and tezacaftor exposure, which may reduce TRIKAFTA efficacy. Therefore, concomitant use is not recommended. ( 5.5 , 7.1 , 12.3 ) Cataracts : Non-congenital lens opacities/cataracts have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow-up examinations are recommended in pediatric patients initiating TRIKAFTA treatment. ( 5.7 , 8.4 ) 5.1 Drug-Induced Liver Injury and Liver Failure TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver ...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Drug-Induced Liver Injury and Liver Failure [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.2) ] Intracranial Hypertension [see Warnings and Precautions (5.3) ] Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.4) ] Cataracts [see Warnings and Precautions (5.7) ] The most common adverse drug reactions to TRIKAFTA (≥5% of patients and at a frequency higher than placebo by ≥1%) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, blood bilirubin increased and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 clinical practice. Patients with Cystic Fibrosis with at Least One F508del Variant The safety profile of TRIKAFTA in patients with CF with at least one F508del variant is based on data from 510 patients aged 12 years and older in two double-blind, controlled trials of 24 weeks and 4 weeks treatment duration (Trials 1 and 2, respectively). Eligible patients were also able to participate in an open-label extension safety study (up to 96 weeks of TRIKAFTA). In the two controlled trials, a total of 257 patients aged 12 years and older received at least one dose of TRIKAFTA. In Trial 1, the proportion of patients who discontinued study drug prematurely due to adverse events was 1% for TRIKAFTA-treated patients and 0% for placebo-treated patients. In Trial 1, serious adverse reactions that occurred more frequently in TRIKAFTA-treated patients compared to placebo were rash (1% vs 5, or >3 × ULN was 1%, 2%, and 8% in TRIKAFTA-treated patients and 1%, 1%, and 5% in placebo-treated patients. The incide...

adverse reactions table

Table 4: Adverse Reactions Occurring in ≥5% of TRIKAFTA-Treated Patients and Higher than Placebo by ≥1% in Trial 1Adverse ReactionsTRIKAFTA N=202 n (%)Placebo N=201 n (%)Headache35 (17)30 (15)Upper respiratory tract infectionIncludes upper respiratory tract infection and viral upper respiratory tract infection.32 (16)25 (12)Abdominal painIncludes abdominal pain, abdominal pain upper, abdominal pain lower.29 (14)18 (9)Diarrhea26 (13)14 (7)RashIncludes rash, rash generalized, rash erythematous, rash macular, rash pruritic.21 (10)10 (5)Alanine aminotransferase increased20 (10)7 (3)Nasal congestion19 (9)15 (7)Blood creatine phosphokinase increased19 (9)9 (4)Aspartate aminotransferase increased19 (9)4 (2)Rhinorrhea17 (8)6 (3)Rhinitis15 (7)11 (5)Influenza14 (7)3 (1)Sinusitis11 (5)8 (4)Blood bilirubin increased10 (5)2 (1)

Additional Listing Data#

Finished product
Yes
Brand name base
Trikafta
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1243046, 1606868, 2174388, 2257011, 2257012, 2257013, 2557214, 2557215, 2557216, 2635013, 2635020, 2635021, 2635022, 2635024, 2635025, 2635026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29f82424-66ff-4356-862a-3564547225eaProduct name120250819
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3345c65e-7c51-4ee3-a410-af7ec8592f92Product name220231010
31b21435-431d-4752-a7c5-89c6a41c6338Product name420230626
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
eaf14f5a-a483-45c2-b6bb-bda37f923e37Product name120180508
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
1c108d2a-865b-9f48-5b3a-b52233297e1dProduct name220150417
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-445-01Trikafta1 in 1 PACKAGEKIT122
51167-445-01Trikafta4 in 1 CARTONKIT422
51167-545-07Trikafta1 in 1 PACKETGRANULE780 mg22
51167-645-07Trikafta1 in 1 PACKETGRANULE759.5 mg22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51167-445-01EA - Each51167-445a481db85-c2bd-4a16-bd23-9dcae0f3165b12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-445TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]20Current NDC, 4 package rows20250215_f354423a-85c2-41c3-a9db-0f3aee135d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2635026{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 75 MG) Granules]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } Pack [Trikafta (80 MG / 40 MG / 60 MG; 59.5 MG) Granules]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 150 MG)]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack [Trikafta (50 MG / 37.5 MG / 25 MG; 75 MG)]BPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } PackGPCKf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635024elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257011elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557214elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635013elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
1243046ivacaftor 150 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635020ivacaftor 59.5 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
1606868ivacaftor 75 MG Oral GranulesPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2174388ivacaftor 75 MG Oral TabletPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635026trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216trikafta 50 MG / 37.5 MG / 25 MG and 75 MG PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules PackPSNf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635024elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257011elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557214elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635013elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
1243046ivacaftor 150 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635020ivacaftor 59.5 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
1606868ivacaftor 75 MG Oral GranulesSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2174388ivacaftor 75 MG Oral TabletSCDf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635025elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257012elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557215elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635021elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2257013trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635026Trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2557216trikafta 50 MG / 37.5 MG / 25 MG and 75 MG PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22
2635022Trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules PackSYf354423a-85c2-41c3-a9db-0f3aee135d8d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51167-445-01511670445014 PACKAGE in 1 CARTON (51167-445-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-545-07) * 1 GRANULE in 1 PACKET (51167-645-07) 4 package2023-04-26NoNoCurrent
51167-545-07511670545071 in 1 PACKETHistorical
51167-645-07511670645071 in 1 PACKETHistorical