Search by Drug Name or NDC

    NDC 70700-0160-19 Ketoconazole 20 mg/g Details

    Ketoconazole 20 mg/g

    Ketoconazole is a TOPICAL AEROSOL, FOAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Xiromed, LLC. The primary component is KETOCONAZOLE.

    Product Information

    NDC 70700-0160
    Product ID 70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69
    Associated GPIs 90154045003920
    GCN Sequence Number 063088
    GCN Sequence Number Description ketoconazole FOAM 2 % TOPICAL
    HIC3 Q5F
    HIC3 Description TOPICAL ANTIFUNGALS
    GCN 98848
    HICL Sequence Number 004132
    HICL Sequence Number Description KETOCONAZOLE
    Brand/Generic Generic
    Proprietary Name Ketoconazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ketoconazole Foam
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form AEROSOL, FOAM
    Route TOPICAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/g
    Substance Name KETOCONAZOLE
    Labeler Name Xiromed, LLC
    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 ANDA213601
    Listing Certified Through 2024-12-31

    Package

    NDC 70700-0160-19 (70700016019)

    NDC Package Code 70700-160-19
    Billing NDC 70700016019
    Package 50 g in 1 CAN (70700-160-19)
    Marketing Start Date 2021-05-21
    NDC Exclude Flag N
    Pricing Information N/A