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    NDC 72485-0222-10 Gemcitabine 1 g/26.3mL Details

    Gemcitabine 1 g/26.3mL

    Gemcitabine is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is GEMCITABINE HYDROCHLORIDE.

    Product Information

    NDC 72485-0222
    Product ID 72485-222_3f1b1931-04c8-45ba-afbb-4daf5e05a69f
    Associated GPIs 21300034102040
    GCN Sequence Number 068084
    GCN Sequence Number Description gemcitabine HCl VIAL 1 G/26.3ML INTRAVEN
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 30776
    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
    Route INTRAVENOUS
    Active Ingredient Strength 1
    Active Ingredient Units g/26.3mL
    Substance Name GEMCITABINE HYDROCHLORIDE
    Labeler Name Armas Pharmaceuticals Inc.
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210991
    Listing Certified Through 2024-12-31

    Package

    NDC 72485-0222-10 (72485022210)

    NDC Package Code 72485-222-10
    Billing NDC 72485022210
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-222-10) / 26.3 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2020-01-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 5b6be4b4-1f0a-4da2-b5d2-2592f401f90b Details

    Revised: 1/2020