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    NDC 00168-0099-30 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 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. The primary component is KETOCONAZOLE.

    Product Information

    NDC 00168-0099
    Product ID 0168-0099_b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee
    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 E. Fougera & Co. a division of Fougera 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 ANDA
    Application Number ANDA076294
    Listing Certified Through 2024-12-31

    Package

    NDC 00168-0099-30 (00168009930)

    NDC Package Code 0168-0099-30
    Billing NDC 00168009930
    Package 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE
    Marketing Start Date 2004-04-28
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.27836
    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 cad7c647-34a9-4e4e-83b3-8d78e58f588f Details

    Revised: 10/2021