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    NDC 00078-0671-19 TYKERB 250 mg/1 Details

    TYKERB 250 mg/1

    TYKERB is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is LAPATINIB DITOSYLATE.

    Product Information

    NDC 00078-0671
    Product ID 0078-0671_3762f7f1-b9c3-4e9f-9249-01f87b0ec407
    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 Brand
    Proprietary Name TYKERB
    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 Novartis Pharmaceuticals Corporation
    Pharmaceutical Class Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022059
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0671-19 (00078067119)

    NDC Package Code 0078-0671-19
    Billing NDC 00078067119
    Package 150 TABLET in 1 BOTTLE (0078-0671-19)
    Marketing Start Date 2016-08-03
    NDC Exclude Flag N
    Pricing Information N/A