Search by Drug Name or NDC

    NDC 42291-0970-60 Zafirlukast 10 mg/1 Details

    Zafirlukast 10 mg/1

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

    Product Information

    NDC 42291-0970
    Product ID 42291-970_fa2bbd50-d0eb-d448-e053-6394a90a4152
    Associated GPIs
    GCN Sequence Number 043557
    GCN Sequence Number Description zafirlukast TABLET 10 MG ORAL
    HIC3 Z4B
    HIC3 Description LEUKOTRIENE RECEPTOR ANTAGONISTS
    GCN 52271
    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, COATED
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name ZAFIRLUKAST
    Labeler Name AvKARE
    Pharmaceutical Class Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA020547
    Listing Certified Through 2024-12-31

    Package

    NDC 42291-0970-60 (42291097060)

    NDC Package Code 42291-970-60
    Billing NDC 42291097060
    Package 60 TABLET, COATED in 1 BOTTLE (42291-970-60)
    Marketing Start Date 2023-04-05
    NDC Exclude Flag N
    Pricing Information N/A