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    NDC 42658-0111-08 Simvastatin 80 mg/1 Details

    Simvastatin 80 mg/1

    Simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hisun Pharmaceuticals USA, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 42658-0111
    Product ID 42658-111_05996dbc-0aa7-0c1a-e063-6294a90a3b67
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Simvastatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Simvastatin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 80
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name Hisun Pharmaceuticals USA, Inc.
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206557
    Listing Certified Through 2024-12-31

    Package

    NDC 42658-0111-08 (42658011108)

    NDC Package Code 42658-111-08
    Billing NDC 42658011108
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (42658-111-08)
    Marketing Start Date 2020-05-01
    NDC Exclude Flag N
    Pricing Information N/A