Search by Drug Name or NDC

    NDC 55111-0687-25 gemcitabine 1 g/25mL Details

    gemcitabine 1 g/25mL

    gemcitabine is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is GEMCITABINE HYDROCHLORIDE.

    Product Information

    NDC 55111-0687
    Product ID 55111-687_f87af163-c123-ad86-b98f-c0e06ab2b1e8
    Associated GPIs 21300034102140
    GCN Sequence Number 025729
    GCN Sequence Number Description gemcitabine HCl VIAL 1 G INTRAVEN
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 38532
    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 1
    Active Ingredient Units g/25mL
    Substance Name GEMCITABINE HYDROCHLORIDE
    Labeler Name Dr. Reddy's Laboratories Limited
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091365
    Listing Certified Through 2024-12-31

    Package

    NDC 55111-0687-25 (55111068725)

    NDC Package Code 55111-687-25
    Billing NDC 55111068725
    Package 1 VIAL, SINGLE-USE in 1 CARTON (55111-687-25) / 25 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2011-07-25
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4 Details

    Revised: 7/2019