TECHNELITE- technetium tc99m generator injection, solution

TechneLite by

Drug Labeling and Warnings

TechneLite by is a Prescription medication manufactured, distributed, or labeled by Lantheus Medical Imaging, Inc., NTP RADIOISOTOPES PTY LTD, Nordion (Canada) Inc, INSTITUT NATIONAL DES RADIOELEMENTS IRE, AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:

  •   Thyroid Imaging
  •   Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
  • CONTRAINDICATIONS

    CONTRAINDICATIONS: None known.

  • WARNINGS

    WARNINGS: Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life-expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

    Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

  • PRECAUTIONS:

    General

    As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.

    Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution.

    After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.

    Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No animal studies have been performed to evaluate carcinogenic potential or whether Sodium Pertechnetate Tc 99m affects fertility in males or females.

    Pregnancy

    Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m. It is also not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Pertechnetate Tc 99m Injection should be given to a pregnant woman only if clearly needed.

    Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

    Nursing Mothers

    Sodium Pertechnetate Tc 99m is excreted in human milk during lactation; therefore formula feedings should be substituted for breast feeding.

    This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks.

    Pediatric Use

    See INDICATIONS and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risks under WARNINGS.

    Geriatric Use

    Clinical studies of TechneLite® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Sodium Pertechnetate Tc 99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m Injection is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.

    The suggested dose range employed for various diagnostic indications in the average ADULT PATIENT (70kg) is:

    Vesico-ureteral Imaging18.5 to 37MBq (0.5 to 1mCi)
    Thyroid Gland Imaging37 to 370MBq (1 to 10mCi)
    Salivary Gland Imaging37 to 185MBq (1 to 5mCi)
    Nasolacrimal Drainage SystemMaximum 3.7MBq (100µCi)

    The recommended dosage range in PEDIATRIC PATIENTS is:

    Vesico-ureteral Imaging18.5 to 37MBq (0.5 to 1mCi)
    Thyroid Gland Imaging2.22 to 2.96MBq (60 to 80µCi)/kg body weight

    The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration of the dose.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution to be administered as the patient dose should be clear and contain no particulate matter. Do not use an eluate of the TECHNELITE®, Technetium Tc 99m Generator later than one (1) working day after elution (12 hours).

    Radiation Dosimetry

    The estimated absorbed radiation doses to an average ADULT and Pediatric patient from an intravenous injection of a maximum dose of 1110MBq (30 millicuries) of Sodium Pertechnetate Tc 99m Injection distributed uniformly in the total body are shown in Tables 5 and 6.

    Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous Injection
    OrganAbsorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose
    To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).
    Adrenals4.1
    Urinary Bladder Wall20
    Bone Surfaces6.2
    Brain2.2
    Breasts2
    Gallbladder Wall8.3
    Stomach Wall29
    Small Intestine18
    ULI Wall63
    LLI Wall23
    Heart Wall3.5
    Kidneys6
    Liver4.7
    Lungs2.9
    Muscle3.6
    Ovaries11
    Pancreas6.3
    Red Marrow4.1
    Skin2
    Spleen4.8
    Testes3.1
    Thymus2.7
    Thyroid24
    Uterus9
    Remaining Tissues3.9
    Effective Dose (mSv)14
    Table 6. Pediatric Absorbed Radiation Doses (mGy) from Intravenous Injection
    Age15 years10 years5 years1 year
    To obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).
    Administered activity in MBq (mCi)
    1110
    (30)
    740
    (20)
    555
    (15)
    370
    (10)
    Organ
    Adrenals5.35.46.27.1
    Urinary Bladder Wall26221822
    Bone Surfaces7.67.58.110
    Brain2.83.13.74.5
    Breasts2.62.63.24.1
    Gallbladder Wall11121313
    Stomach Wall38364359
    Small Intestine22232630
    ULI Wall8189110140
    LLI Wall31334048
    Heart Wall4.54.65.26.4
    Kidneys7.26.97.88.5
    Liver66.789.1
    Lungs3.83.84.45.3
    Muscle4.54.556
    Ovaries14131417
    Pancreas8.18.28.910
    Red Marrow5.155.26
    Skin2.52.63.23.8
    Spleen666.77.8
    Testes4.14.34.96
    Thymus3.63.54.25.3
    Thyroid40416781
    Uterus11111214
    Remaining Tissues4.84.85.46.4
    Effective Dose (mSv)19192329

    The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc 99m Injection for imaging the nasolacrimal drainage system are shown in Table 7.

    Table 7. Absorbed Radiation Dose from Dacryoscintigraphy Using Sodium Pertechnetate Tc 99m
    Absorbed Dose
    Target OrganmGy/
    3.7MBq
    (rad/
    100µCi)
    * Assuming no blockage of drainage system
    Eye Lens:
      If lacrimal fluid turnover is 16%/min
      If lacrimal fluid turnover is 100%/min
      If drainage system is blocked
    Total Body*
    Ovaries*
    Testes*
    Thyroid*

    0.140
    0.022
    4.020
    0.011
    0.030
    0.009
    0.130

    0.014
    0.002
    0.402
    0.001
    0.003
    0.001
    0.013

    In pediatric patients, an average 30 minute exposure to 37MBq (1 millicurie) of Sodium Pertechnetate Tc 99m Injection following instillation for direct cystography, results in an estimated absorbed radiation dose shown in Table 8.

    Table 8. Pediatric Absorbed Radiation Dose from Cystography
    AgeBladder wall dose, mGy (rad)Gonadal dose,
    mGy (rad)
    1 year3.6 (0.36)0.15 (0.015)
    5 years2.0 (0.2)0.095 (0.0095)
    10 years1.3 (0.13)0.066 (0.0066)
    15 years0.92 (0.092)0.046 (0.0046)
  • HOW SUPPLIED

    HOW SUPPLIED: Lantheus Medical Imaging TECHNELITE®, Technetium Tc 99m Generator is available in the following quantities of radioactivity of Mo99 on the calibration date (date of manufacture) as specified on the product lot identification label affixed to the generator:

    Table 9 Available Quantities of Radioactivity
    High Enriched Uranium (HEU)Low Enriched Uranium (LEU)
    NDC #GBq of Mo99Ci of Mo99NDC #GBq of Mo99Ci of Mo99
    11994-090-3637.0111994-091-3637.01
    11994-090-7374.0211994-091-7374.02
    11994-090-9292.52.511994-091-9292.52.5
    11994-090-01111.0311994-091-01111.03
    11994-090-03148.0411994-091-03148.04
    11994-090-04166.54.511994-091-04166.54.5
    11994-090-05185.0511994-091-05185.05
    11994-090-06222.0611994-091-06222.06
    11994-090-07277.57.511994-091-07277.57.5
    11994-090-09370.01011994-091-09370.010
    11994-090-10462.512.511994-091-10462.512.5
    11994-090-11555.01511994-091-11555.015
    11994-090-12666.01811994-091-12666.018
    11994-090-13740.02011994-091-13740.020

    Each generator is supplied with the following standard components:

  •   Collect Needle Seal Vial
  •   Eluant Charge Vials (may be supplied separately)
  •   Eluate Collection Vials (may be supplied separately)
  •   1 Package Insert
  •   6 Radiation Labels (Collection Vial)
  •   6 Radiation Labels (Eluting Shield)
  • First order generators are shipped with the following accessory components:

  •   2 Eluting Shields
  • Additional quantities of these components may be obtained at the customer's request.

  • STORAGE AND HANDLING

    STORAGE: Controlled room temperature 20° to 25°C (68° to 77°F) [See USP].

  • SPL UNCLASSIFIED SECTION

    EXPIRATION: The expiration time of the Sodium Pertechnetate Tc 99m solution is not later than 12 hours after elution. If the eluate is to be used to reconstitute a kit for the preparation of a Technetium Tc 99m radiopharmaceutical, the kit should not be used after 12 hours from time of Generator elution or after the expiration time stated on the labeling for the prepared drug, whichever is earlier.

    The generator should not be used after the expiration date stated on the label.

  • SPL UNCLASSIFIED SECTION

    ELUTION INSTRUCTIONS - TOTAL ELUTION METHOD

    1. Waterproof gloves should be worn during elution.
    2. Remove dust (clear plastic) cover of generator.
    3. Perform all subsequent operations aseptically.
    4. Remove silicone needle seal from eluant charge well. Discard as radioactive waste.
    5. Remove flip-off seal and swab septum of eluant charge vial with a bactericide (such as 70% isopropyl alcohol), allow to dry, and insert the vial into charge well. Vial should be firmly inserted to assure puncture of septum. Caution: Excessive use of bactericides containing alcohol may adversely affect Technetium Tc 99m yield.
    6. Open elution shield base and insert an eluate collection vial from which the flip-off seal has been removed. Screw base back on securely. Swab the exposed vial septum with a bactericide and allow to dry.
    7. Remove vented needle cover from collect well. Discard as radioactive waste.
    8. Insert shielded eluate collection vial in collect well. Elution should commence within 30 seconds and can be visually checked by the appearance of bubbles in the eluant charge vial. To assure proper yield and functioning, elution must proceed to completion as evidenced by emptying of the charge vial. Allow generator to elute for at least 3 minutes after the charge has been drained, or for a total of 6 minutes.
      ****NOTE 1 (non-eluting generator): If bubbles do not appear in the eluant charge vial within 30 seconds, remove the eluate collection vial to prevent vacuum loss; then remove and reinsert the charge vial. Reinsert the eluate collection vial and if elution does not commence, use a second shielded collection vial. If the elution still does not commence, contact Lanthues Medical Imaging, Inc.
      ****NOTE 2 (partial eluting generator): If the saline charge vial does not fully empty or the expected eluate volume is not recovered, remove the evacuated collection vial and the saline charge vial. Insert a new saline charge vial and a new evacuated collection vial. Allow the elution process to complete. If the replacement saline charge vial does not fully empty or the expected eluate volume is not recovered in the replacement collection vial, contact Lantheus Medical Imaging, Inc. DO NOT USE ELUATE COLLECTED FROM A PARTIALLY ELUTED GENERATOR.
      Caution: Tampering with the internal components could compromise sterility and present a radiation hazard. This generator should not be dismantled.
    9. After elution has been completed, remove shield containing the collection vial. Obtain the collect needle seal vial, and using a bactericide, swab the septum of the collect needle seal vial and insert over the collect needle. The eluant vial is sterile and should stay in place until the next elution, functioning as a seal for the needles within the charge well. Upon initiating the next elution, discard the empty eluant vial as radioactive waste.
    10. Perform the Assay and Radiometric Molybdenum Test Procedures described below for each elution performed.
    11. Fill out and attach the appropriate supplied pressure sensitive radioactivity labels to the elution shield containing the filled eluate collection vial. Do not use an eluate of the Technetium Tc 99m Generator later than 1 working day after the time of elution (12 hours).
    12. Use a shielded syringe when introducing the Sodium Pertechnetate Tc 99m solution into mixing vials.
    13. Maintain adequate shielding during the life of the radioactive preparation by using a lead vial shield and cover, and use a shielded syringe for withdrawing and injecting the preparation.

    ASSAY INSTRUCTIONS FOR THE TECHNELITE®, TECHNETIUM Tc 99m GENERATOR ELUATE

    The TECHNELITE®, Technetium Tc 99m Generator Eluate may be assayed using an ionization chamber dose calibrator. The manufacturer's instructions for operation of the dose calibrator should be followed for measurement of Technetium Tc 99m and Molybdenum Mo99 activity in the generator eluate. The Molybdenum 99/Technetium 99m ratio is to be determined at the time of each elution prior to administration, and from that ratio, the expiration time (up to 12 hours) of the eluate mathematically determined. Each eluate must meet or exceed the purity requirements of the current United States Pharmacopeia; that is, not more than 0.0056MBq (0.15 microcurie) of Molybdenum 99 per 37MBq (1 millicurie) of Technetium 99m per administered dose at the time of administration.

    RADIOMETRIC MOLYBDENUM TEST PROCEDURE

    This method is based on the fact that most Technetium Tc 99m radiation can be readily shielded and only the more energetic gamma rays from Molybdenum Mo99 (739KeV and 778KeV) are counted in the 550-850KeV energy range. The entire eluate may be assayed for Molybdenum Mo99 activity as follows:

    1. A Cesium Cs 137 reference source which has the same geometry as the generator eluate must be used to standardize the well counter.
    2. Determine the background after setting the window to the 550-850KeV energy range.
    3. Count the Technetium Tc 99m eluate in its lead shield (thereby shielding out Technetium Tc 99m) by placing over the well or probe.
    4. Count the Cs 137 reference source in the same shield geometry for the same time period.
    5. Compute Molybdenum Mo99 activity in the eluate as follows:

      µCi Molybdenum      =        µCi simulated Mo99 x net cpm Eluate  
      Mo99 (total)                        net cpm simulated Mo99 reference source

    Divide this number by the mCi of Technetium Tc 99m. This result (µCi Mo99/mCi Tc 99m) can be converted to MBq Mo99/MBq Tc 99m by multiplying by 10-3. The U.S. Pharmacopeia and the U.S. Nuclear Regulatory Commission or equivalent Agreement State regulations specify a limit of 0.00015MBq Molybdenum Mo99 per MBq of Technetium Tc 99m (0.15µCi Mo99/mCi Tc 99m) at the time of administration to each patient. If this limit is exceeded, the eluate should not be used. Discard the eluate and contact Lantheus Medical Imaging, Inc.

    COLORIMETRIC ALUMINUM ION TEST PROCEDURE

    Obtain an aluminum ion indicator kit and determine the aluminum ion concentration of the eluate per the manufacturer's instructions. The concentration must not exceed 10 micrograms per milliliter of eluate.

  • SPL UNCLASSIFIED SECTION

    DISPOSAL: All components shipped with the TECHNELITE®, Technetium Tc 99m Generator should be monitored for contamination prior to disposing into routine trash systems. The Technetium Tc 99m should not be disposed of into routine trash systems. The generator should be disposed through a USNRC or Agreement State licensed disposal agency or by a method approved by the appropriate regulatory authority. Spent generators may be returned; complete return instructions are available on request.

    This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commision, an Agreement State or a Licensing State.

  • SPL UNCLASSIFIED SECTION

    Lantheus
    Medical Imaging

    331 Treble Cove Road
    N. Billerica, MA 01862 USA
    For Ordering Call Toll-Free: 800-299-3431 All other business: 800-362-2668
    (In Massachusetts and International, call 978-667-9531)

    Patent: http://www.lantheus.com/patents/index.html

    Lantheus
    Medical Imaging


    Printed in U.S.A.

    513160-0719
    July 2019

  • PRINCIPAL DISPLAY PANEL - Vial Carton

    515128-0811

    Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection
    TechneLite®
    Molybdenum Mo 99-Technetium Tc 99m Generator

    Rx only.

    See Package Insert for dosing information.

    Canadian Est. Lic. No. 101647-A AUSTR R 130301

    Store at controlled room temperature 20° to 25°C
    (68° to 77°F) [See USP]. Eluate must be used within
    12 hours of elution.

    CAUTION: This generator should not be dismantled.

    Manufacturer:
    Lantheus
    Medical Imaging®

    N. Billerica, Massachusetts 01862 USA

    Canadian License Holder:
    Lantheus MI Canada, Inc.
    Montréal, Canada
    Australian Sponsor:
    Lantheus MI Australia Pty Ltd.

    CAUTION:
    RADIOACTIVE MATERIAL

    PRINCIPAL DISPLAY PANEL - Vial Carton
  • PRINCIPAL DISPLAY PANEL - Vial Carton

    515128-0811

    Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection
    TechneLite®
    Molybdenum Mo 99-Technetium Tc 99m Generator

    Rx only.

    See Package Insert for dosing information.

    Canadian Est. Lic. No. 101647-A AUSTR R 130301

    Store at controlled room temperature 20° to 25°C
    (68° to 77°F) [See USP]. Eluate must be used within
    12 hours of elution.

    CAUTION: This generator should not be dismantled.

    Manufacturer:
    Lantheus
    Medical Imaging®

    N. Billerica, Massachusetts 01862 USA

    Canadian License Holder:
    Lantheus MI Canada, Inc.
    Montréal, Canada
    Australian Sponsor:
    Lantheus MI Australia Pty Ltd.

    CAUTION:
    RADIOACTIVE MATERIAL

    PRINCIPAL DISPLAY PANEL - Vial Carton
  • INGREDIENTS AND APPEARANCE
    TECHNELITE 
    technetium tc99m generator injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 11994-090
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TECHNETIUM TC-99M SODIUM PERTECHNETATE (UNII: A0730CX801) (TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) MOLYBDENUM MO-99250 mCi  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 11994-090-361 in 1 CARTON11/01/1975
    14 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC: 11994-090-731 in 1 CARTON11/01/1975
    28 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC: 11994-090-921 in 1 CARTON11/01/1975
    310 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC: 11994-090-011 in 1 CARTON11/01/1975
    412 mL in 1 VIAL; Type 0: Not a Combination Product
    5NDC: 11994-090-031 in 1 CARTON11/01/1975
    516 mL in 1 VIAL; Type 0: Not a Combination Product
    6NDC: 11994-090-041 in 1 CARTON11/01/1975
    618 mL in 1 VIAL; Type 0: Not a Combination Product
    7NDC: 11994-090-051 in 1 CARTON11/01/1975
    720 mL in 1 VIAL; Type 0: Not a Combination Product
    8NDC: 11994-090-061 in 1 CARTON11/01/1975
    824 mL in 1 VIAL; Type 0: Not a Combination Product
    9NDC: 11994-090-071 in 1 CARTON11/01/1975
    930 mL in 1 VIAL; Type 0: Not a Combination Product
    10NDC: 11994-090-091 in 1 CARTON11/01/1975
    1040 mL in 1 VIAL; Type 0: Not a Combination Product
    11NDC: 11994-090-101 in 1 CARTON11/01/1975
    1150 mL in 1 VIAL; Type 0: Not a Combination Product
    12NDC: 11994-090-111 in 1 CARTON11/01/1975
    1260 mL in 1 VIAL; Type 0: Not a Combination Product
    13NDC: 11994-090-121 in 1 CARTON11/01/1975
    1372 mL in 1 VIAL; Type 0: Not a Combination Product
    14NDC: 11994-090-131 in 1 CARTON11/01/1975
    1480 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01777111/01/1975
    TECHNELITE 
    technetium tc99m generator injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 11994-091
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TECHNETIUM TC-99M SODIUM PERTECHNETATE (UNII: A0730CX801) (TECHNETIUM TC-99M PERTECHNETATE - UNII:PPP8783IQ1) MOLYBDENUM MO-99250 mCi  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 11994-091-361 in 1 CARTON09/28/2010
    14 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC: 11994-091-731 in 1 CARTON09/28/2010
    28 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC: 11994-091-921 in 1 CARTON09/28/2010
    310 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC: 11994-091-011 in 1 CARTON09/28/2010
    412 mL in 1 VIAL; Type 0: Not a Combination Product
    5NDC: 11994-091-031 in 1 CARTON09/28/2010
    516 mL in 1 VIAL; Type 0: Not a Combination Product
    6NDC: 11994-091-041 in 1 CARTON09/28/2010
    618 mL in 1 VIAL; Type 0: Not a Combination Product
    7NDC: 11994-091-051 in 1 CARTON09/28/2010
    720 mL in 1 VIAL; Type 0: Not a Combination Product
    8NDC: 11994-091-061 in 1 CARTON09/28/2010
    824 mL in 1 VIAL; Type 0: Not a Combination Product
    9NDC: 11994-091-071 in 1 CARTON09/28/2010
    930 mL in 1 VIAL; Type 0: Not a Combination Product
    10NDC: 11994-091-091 in 1 CARTON09/28/2010
    1040 mL in 1 VIAL; Type 0: Not a Combination Product
    11NDC: 11994-091-101 in 1 CARTON09/28/2010
    1150 mL in 1 VIAL; Type 0: Not a Combination Product
    12NDC: 11994-091-111 in 1 CARTON09/28/2010
    1260 mL in 1 VIAL; Type 0: Not a Combination Product
    13NDC: 11994-091-121 in 1 CARTON09/28/2010
    1372 mL in 1 VIAL; Type 0: Not a Combination Product
    14NDC: 11994-091-131 in 1 CARTON09/28/2010
    1480 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01777111/01/1975
    Labeler - Lantheus Medical Imaging, Inc. (176786812)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lantheus Medical Imaging, Inc.176786812LABEL(11994-090, 11994-091) , MANUFACTURE(11994-090, 11994-091) , PACK(11994-090, 11994-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    NTP RADIOISOTOPES PTY LTD639063861ANALYSIS(11994-090, 11994-091) , API MANUFACTURE(11994-090, 11994-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    INSTITUT NATIONAL DES RADIOELEMENTS IRE283049187ANALYSIS(11994-090, 11994-091) , API MANUFACTURE(11994-090, 11994-091)
    Establishment
    NameAddressID/FEIBusiness Operations
    AUSTRALIAN NUCLEAR SCIENCE AND TECHNOLOGY ORGANIZATION DBA AUSTRALIAN RADIOPHARMACEUTICAL AND INDUSTRIALS750911232API MANUFACTURE(11994-090, 11994-091)

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