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    NDC 68382-0915-84 Erlotinib 150 mg/1 Details

    Erlotinib 150 mg/1

    Erlotinib is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is ERLOTINIB HYDROCHLORIDE.

    Product Information

    NDC 68382-0915
    Product ID 68382-915_e34fafdf-2fda-4031-9202-6d7e85925dc1
    Associated GPIs 21360025100360
    GCN Sequence Number 058374
    GCN Sequence Number Description erlotinib HCl TABLET 150 MG ORAL
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 23793
    HICL Sequence Number 026745
    HICL Sequence Number Description ERLOTINIB HCL
    Brand/Generic Generic
    Proprietary Name Erlotinib
    Proprietary Name Suffix n/a
    Non-Proprietary Name Erlotinib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 150
    Active Ingredient Units mg/1
    Substance Name ERLOTINIB HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213065
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0915-84 (68382091584)

    NDC Package Code 68382-915-84
    Billing NDC 68382091584
    Package 3 BLISTER PACK in 1 CARTON (68382-915-84) / 10 TABLET in 1 BLISTER PACK (68382-915-30)
    Marketing Start Date 2020-04-30
    NDC Exclude Flag N
    Pricing Information N/A