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    NDC 00378-7007-01 Ketaconazole 20 mg/g Details

    Ketaconazole 20 mg/g

    Ketaconazole is a TOPICAL AEROSOL, FOAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is KETOCONAZOLE.

    Product Information

    NDC 00378-7007
    Product ID 0378-7007_d7dc70c0-ca7d-42cc-bf8e-13dd6459ebb7
    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 Ketaconazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name Ketaconazole
    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 Mylan Pharmaceuticals Inc.
    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 NDA AUTHORIZED GENERIC
    Application Number NDA021738
    Listing Certified Through 2023-12-31

    Package

    NDC 00378-7007-01 (00378700701)

    NDC Package Code 0378-7007-01
    Billing NDC 00378700701
    Package 1 CAN in 1 CARTON (0378-7007-01) / 100 g in 1 CAN
    Marketing Start Date 2018-12-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d7dc70c0-ca7d-42cc-bf8e-13dd6459ebb7 Details

    Revised: 9/2018