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    NDC 43063-0080-30 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 PD-Rx Pharmaceuticals, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 43063-0080
    Product ID 43063-080_06441212-4067-621e-e063-6394a90a754a
    Associated GPIs 39400075000360
    GCN Sequence Number 040238
    GCN Sequence Number Description simvastatin TABLET 80 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 26535
    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 80
    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 ANDA077752
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0080-30 (43063008030)

    NDC Package Code 43063-080-30
    Billing NDC 43063008030
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-080-30)
    Marketing Start Date 2009-03-04
    NDC Exclude Flag N
    Pricing Information N/A