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    NDC 63629-8820-01 Ketoconazole 20 mg/g Details

    Ketoconazole 20 mg/g

    Ketoconazole is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is KETOCONAZOLE.

    Product Information

    NDC 63629-8820
    Product ID 63629-8820_21bd4467-5a52-41b8-b583-6bff890cf499
    Associated GPIs 90154045003710
    GCN Sequence Number 007334
    GCN Sequence Number Description ketoconazole CREAM (G) 2 % TOPICAL
    HIC3 Q5F
    HIC3 Description TOPICAL ANTIFUNGALS
    GCN 31850
    HICL Sequence Number 004132
    HICL Sequence Number Description KETOCONAZOLE
    Brand/Generic Generic
    Proprietary Name Ketoconazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ketoconazole
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CREAM
    Route TOPICAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/g
    Substance Name KETOCONAZOLE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075581
    Listing Certified Through 2025-12-31

    Package

    NDC 63629-8820-01 (63629882001)

    NDC Package Code 63629-8820-1
    Billing NDC 63629882001
    Package 1 TUBE in 1 CARTON (63629-8820-1) / 60 g in 1 TUBE
    Marketing Start Date 2021-09-10
    NDC Exclude Flag N
    Pricing Information N/A