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    NDC 65862-0054-39 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 Aurobindo Pharma Limited. The primary component is SIMVASTATIN.

    Product Information

    NDC 65862-0054
    Product ID 65862-054_7aa9abed-6d40-4370-aeac-4d34e2cf0416
    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 Aurobindo Pharma Limited
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077691
    Listing Certified Through 2025-12-31

    Package

    NDC 65862-0054-39 (65862005439)

    NDC Package Code 65862-054-39
    Billing NDC 65862005439
    Package 3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39)
    Marketing Start Date 2006-12-20
    NDC Exclude Flag N
    Pricing Information N/A