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    NDC 50742-0463-16 DOCETAXEL 10 mg/mL Details

    DOCETAXEL 10 mg/mL

    DOCETAXEL is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ingenus Pharmaceuticals, LLC. The primary component is DOCETAXEL ANHYDROUS.

    Product Information

    NDC 50742-0463
    Product ID 50742-463_831c6991-9cc6-48cf-8414-f254746507d8
    Associated GPIs 21500005002050
    GCN Sequence Number 067169
    GCN Sequence Number Description docetaxel VIAL 160MG/16ML INTRAVEN
    HIC3 V1F
    HIC3 Description ANTINEOPLASTICS,MISCELLANEOUS
    GCN 29664
    HICL Sequence Number 010280
    HICL Sequence Number Description DOCETAXEL
    Brand/Generic Generic
    Proprietary Name DOCETAXEL
    Proprietary Name Suffix n/a
    Non-Proprietary Name DOCETAXEL ANHYDROUS
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name DOCETAXEL ANHYDROUS
    Labeler Name Ingenus Pharmaceuticals, LLC
    Pharmaceutical Class Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207563
    Listing Certified Through 2024-12-31

    Package

    NDC 50742-0463-16 (50742046316)

    NDC Package Code 50742-463-16
    Billing NDC 50742046316
    Package 1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16) / 16 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 2017-09-07
    NDC Exclude Flag N
    Pricing Information N/A