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    NDC 16729-0007-10 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 Accord Healthcare, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 16729-0007
    Product ID 16729-007_ff92b67e-c659-c9e0-e053-6394a90af562
    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 Accord Healthcare, 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 16729-0007-10 (16729000710)

    NDC Package Code 16729-007-10
    Billing NDC 16729000710
    Package 30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10)
    Marketing Start Date 2008-02-26
    NDC Exclude Flag N
    Pricing Information N/A