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    NDC 00143-9394-01 Gemcitabine 200 mg/1 Details

    Gemcitabine 200 mg/1

    Gemcitabine is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is GEMCITABINE.

    Product Information

    NDC 00143-9394
    Product ID 0143-9394_37afef8b-07d8-4857-934a-ddea3296e592
    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
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name GEMCITABINE
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206617
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9394-01 (00143939401)

    NDC Package Code 0143-9394-01
    Billing NDC 00143939401
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9394-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2021-06-25
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 70558689-02e9-4466-9fc6-6c684b2ffbf3 Details

    Revised: 6/2021