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    NDC 25021-0234-10 gemcitabine 200 mg/5mL Details

    gemcitabine 200 mg/5mL

    gemcitabine is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is GEMCITABINE HYDROCHLORIDE.

    Product Information

    NDC 25021-0234
    Product ID 25021-234_8c16221f-8a11-4ad2-b1ab-dc06f080d90f
    Associated GPIs 21300034102110
    GCN Sequence Number 025728
    GCN Sequence Number Description gemcitabine HCl VIAL 200 MG INTRAVEN
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 38530
    HICL Sequence Number 010798
    HICL Sequence Number Description GEMCITABINE HCL
    Brand/Generic Generic
    Proprietary Name gemcitabine
    Proprietary Name Suffix n/a
    Non-Proprietary Name gemcitabine hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units mg/5mL
    Substance Name GEMCITABINE HYDROCHLORIDE
    Labeler Name Sagent Pharmaceuticals
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202485
    Listing Certified Through 2024-12-31

    Package

    NDC 25021-0234-10 (25021023410)

    NDC Package Code 25021-234-10
    Billing NDC 25021023410
    Package 1 VIAL in 1 CARTON (25021-234-10) / 5 mL in 1 VIAL
    Marketing Start Date 2014-12-29
    NDC Exclude Flag N
    Pricing Information N/A