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    NDC 60505-4512-03 Gefitinib 250 mg/1 Details

    Gefitinib 250 mg/1

    Gefitinib is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is GEFITINIB.

    Product Information

    NDC 60505-4512
    Product ID 60505-4512_5fb92c16-3e0f-f445-ede2-9e6db77c6e10
    Associated GPIs
    GCN Sequence Number 052086
    GCN Sequence Number Description gefitinib TABLET 250 MG ORAL
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 19586
    HICL Sequence Number 025178
    HICL Sequence Number Description GEFITINIB
    Brand/Generic Generic
    Proprietary Name Gefitinib
    Proprietary Name Suffix n/a
    Non-Proprietary Name Gefitinib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 250
    Active Ingredient Units mg/1
    Substance Name GEFITINIB
    Labeler Name Apotex Corp.
    Pharmaceutical Class Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209532
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-4512-03 (60505451203)

    NDC Package Code 60505-4512-3
    Billing NDC 60505451203
    Package 30 TABLET in 1 BOTTLE (60505-4512-3)
    Marketing Start Date 2023-08-08
    NDC Exclude Flag N
    Pricing Information N/A