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    NDC 47335-0994-36 Winlevi 1 g/100g Details

    Winlevi 1 g/100g

    Winlevi is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is CLASCOTERONE.

    Product Information

    NDC 47335-0994
    Product ID 47335-994_d78b5354-95c8-4bba-99a5-9cb339735547
    Associated GPIs 90050011003720
    GCN Sequence Number 081428
    GCN Sequence Number Description clascoterone CREAM (G) 1 % TOPICAL
    HIC3 Q50
    HIC3 Description TOPICAL ANTIANDROGENIC AGENTS
    GCN 48534
    HICL Sequence Number 046803
    HICL Sequence Number Description CLASCOTERONE
    Brand/Generic Brand
    Proprietary Name Winlevi
    Proprietary Name Suffix n/a
    Non-Proprietary Name Clascoterone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CREAM
    Route TOPICAL
    Active Ingredient Strength 1
    Active Ingredient Units g/100g
    Substance Name CLASCOTERONE
    Labeler Name Sun Pharmaceutical Industries, Inc.
    Pharmaceutical Class Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA213433
    Listing Certified Through 2024-12-31

    Package

    NDC 47335-0994-36 (47335099436)

    NDC Package Code 47335-994-36
    Billing NDC 47335099436
    Package 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE
    Marketing Start Date 2021-10-04
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 9.3052
    Pricing Unit GM
    Effective Date 2023-08-23
    NDC Description WINLEVI 1% CREAM
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 2, 5
    Classification for Rate Setting B
    As of Date 2024-02-21
    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