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    NDC 00093-3219-92 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 Teva Pharmaceuticals USA, Inc.. The primary component is KETOCONAZOLE.

    Product Information

    NDC 00093-3219
    Product ID 0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f
    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 Teva Pharmaceuticals USA, 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 ANDA
    Application Number ANDA075581
    Listing Certified Through 2024-12-31

    Package

    NDC 00093-3219-92 (00093321992)

    NDC Package Code 0093-3219-92
    Billing NDC 00093321992
    Package 1 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBE
    Marketing Start Date 2019-02-08
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.2232
    Pricing Unit GM
    Effective Date 2022-11-23
    NDC Description KETOCONAZOLE 2% CREAM
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL 7fc47a6a-3714-4598-ae3b-d5a229262c21 Details

    Revised: 9/2021