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    NDC 59651-0292-60 Zafirlukast 20 mg/1 Details

    Zafirlukast 20 mg/1

    Zafirlukast is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ZAFIRLUKAST.

    Product Information

    NDC 59651-0292
    Product ID 59651-292_8bdb47c5-9d19-4d59-94c8-62c117525e7f
    Associated GPIs
    GCN Sequence Number 027962
    GCN Sequence Number Description zafirlukast TABLET 20 MG ORAL
    HIC3 Z4B
    HIC3 Description LEUKOTRIENE RECEPTOR ANTAGONISTS
    GCN 18690
    HICL Sequence Number 011815
    HICL Sequence Number Description ZAFIRLUKAST
    Brand/Generic Generic
    Proprietary Name Zafirlukast
    Proprietary Name Suffix n/a
    Non-Proprietary Name Zafirlukast
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name ZAFIRLUKAST
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA213163
    Listing Certified Through 2024-12-31

    Package

    NDC 59651-0292-60 (59651029260)

    NDC Package Code 59651-292-60
    Billing NDC 59651029260
    Package 60 TABLET, FILM COATED in 1 BOTTLE (59651-292-60)
    Marketing Start Date 2023-11-27
    NDC Exclude Flag N
    Pricing Information N/A