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    NDC 63629-8675-01 Ketoconazole 20 mg/mL Details

    Ketoconazole 20 mg/mL

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

    Product Information

    NDC 63629-8675
    Product ID 63629-8675_00c5f013-5979-a3d5-e063-6294a90a43d3
    Associated GPIs
    GCN Sequence Number 015568
    GCN Sequence Number Description ketoconazole SHAMPOO 2 % TOPICAL
    HIC3 Q5F
    HIC3 Description TOPICAL ANTIFUNGALS
    GCN 31271
    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 SHAMPOO, SUSPENSION
    Route TOPICAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/mL
    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 ANDA076419
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-8675-01 (63629867501)

    NDC Package Code 63629-8675-1
    Billing NDC 63629867501
    Package 120 mL in 1 BOTTLE (63629-8675-1)
    Marketing Start Date 2022-02-09
    NDC Exclude Flag N
    Pricing Information N/A