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    NDC 43063-0008-30 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 PD-Rx Pharmaceuticals, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 43063-0008
    Product ID 43063-008_05b7adf3-2287-e3c8-e063-6294a90a3ab6
    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 PD-Rx Pharmaceuticals, Inc.
    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 43063-0008-30 (43063000830)

    NDC Package Code 43063-008-30
    Billing NDC 43063000830
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-008-30)
    Marketing Start Date 2019-06-07
    NDC Exclude Flag N
    Pricing Information N/A