Search by Drug Name or NDC

    NDC 43063-0733-30 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 43063-0733
    Product ID 43063-733_05b8ed39-74cd-f32b-e063-6294a90a3895
    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 ANDA078155
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0733-30 (43063073330)

    NDC Package Code 43063-733-30
    Billing NDC 43063073330
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30)
    Marketing Start Date 2016-12-28
    NDC Exclude Flag N
    Pricing Information N/A