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    NDC 68180-0801-36 Lapatinib 250 mg/1 Details

    Lapatinib 250 mg/1

    Lapatinib is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is LAPATINIB DITOSYLATE.

    Product Information

    NDC 68180-0801
    Product ID 68180-801_83e11e1b-056e-4c28-b2d3-825ff1b804e1
    Associated GPIs 21533026100320
    GCN Sequence Number 062364
    GCN Sequence Number Description lapatinib ditosylate TABLET 250 MG ORAL
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 98140
    HICL Sequence Number 034541
    HICL Sequence Number Description LAPATINIB DITOSYLATE
    Brand/Generic Generic
    Proprietary Name Lapatinib
    Proprietary Name Suffix n/a
    Non-Proprietary Name lapatinib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 250
    Active Ingredient Units mg/1
    Substance Name LAPATINIB DITOSYLATE
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203007
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0801-36 (68180080136)

    NDC Package Code 68180-801-36
    Billing NDC 68180080136
    Package 150 TABLET in 1 BOTTLE (68180-801-36)
    Marketing Start Date 2020-09-29
    NDC Exclude Flag N
    Pricing Information N/A