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    NDC 61919-0446-90 SIMVASTATIN 20 mg/1 Details

    SIMVASTATIN 20 mg/1

    SIMVASTATIN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Direct Rx. The primary component is SIMVASTATIN.

    Product Information

    NDC 61919-0446
    Product ID 61919-446_f2143778-2cb4-70cf-e053-2995a90afba8
    Associated GPIs 39400075000330
    GCN Sequence Number 016578
    GCN Sequence Number Description simvastatin TABLET 20 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 26533
    HICL Sequence Number 006312
    HICL Sequence Number Description SIMVASTATIN
    Brand/Generic Generic
    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 20
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name Direct Rx
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078155
    Listing Certified Through 2024-12-31

    Package

    NDC 61919-0446-90 (61919044690)

    NDC Package Code 61919-446-90
    Billing NDC 61919044690
    Package 90 TABLET, FILM COATED in 1 BOTTLE (61919-446-90)
    Marketing Start Date 2014-11-14
    NDC Exclude Flag N
    Pricing Information N/A