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    NDC 00054-0249-22 Imatinib Mesylate 400 mg/1 Details

    Imatinib Mesylate 400 mg/1

    Imatinib Mesylate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is IMATINIB MESYLATE.

    Product Information

    NDC 00054-0249
    Product ID 0054-0249_6bee6fa5-7883-4e39-b381-e2ed52f566e1
    Associated GPIs 21531835100340
    GCN Sequence Number 052711
    GCN Sequence Number Description imatinib mesylate TABLET 400 MG ORAL
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 19907
    HICL Sequence Number 022096
    HICL Sequence Number Description IMATINIB MESYLATE
    Brand/Generic Generic
    Proprietary Name Imatinib Mesylate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Imatinib Mesylate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 400
    Active Ingredient Units mg/1
    Substance Name IMATINIB MESYLATE
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207586
    Listing Certified Through 2023-12-31

    Package

    NDC 00054-0249-22 (00054024922)

    NDC Package Code 0054-0249-22
    Billing NDC 00054024922
    Package 90 TABLET, FILM COATED in 1 BOTTLE (0054-0249-22)
    Marketing Start Date 2018-09-28
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 0e9927ab-771e-4c2d-881e-7031c40bf205 Details

    Revised: 8/2022