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ELOXATIN (Aventis Pharma Ltd.)

Available Formats

Dosage Form Package Information Links
INJECTION, SOLUTION, CONCENTRATE 240 VIAL, SINGLE-USE in 1 CASE (12516-0592-4) > 40 mL in 1 VIAL, SINGLE-USE Label Information

Complete ELOXATIN Information

  • PRINCIPAL DISPLAY PANEL - Bulk Shipping Label

    NDC 12516-0592-4

    ELOXATIN® (oxaliplatin injection)
    200 mg/40mL vial

    GMID PACK CODE: 315927

    QUANTITY: 240 vials

    LOT: **********

    DATE MFD:

    EXP: **********

    PROCESS ORDER No: **********

    WEIGHT: 20.6kg

    Caution: For manufacturing, processing or repacking.

    Rx only.

    Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

    Do not freeze and protect from light

    Manufactured by:
    Aventis Pharma Ltd. Rainham Rd South, Dagenham, Essex, RM10 7XS, UK

    Made in UK

    326925

    Bulk Shipping Label

  • INGREDIENTS AND APPEARANCE
    ELOXATIN 
    oxaliplatin injection, solution, concentrate
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12516-0592
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    oxaliplatin (UNII: 04ZR38536J) (oxaliplatin - UNII:04ZR38536J) oxaliplatin 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12516-0592-4 240 in 1 CASE
    1 40 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021759 07/22/2009
    Labeler - Aventis Pharma Ltd. (737163787)
    Establishment
    Name Address ID/FEI Business Operations
    Aventis Pharma Ltd. 737163787 MANUFACTURE