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    NDC 65862-0053-00 Simvastatin 40 mg/1 Details

    Simvastatin 40 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 65862-0053
    Product ID 65862-053_7aa9abed-6d40-4370-aeac-4d34e2cf0416
    Associated GPIs 39400075000340
    GCN Sequence Number 016579
    GCN Sequence Number Description simvastatin TABLET 40 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 26534
    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 40
    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 65862-0053-00 (65862005300)

    NDC Package Code 65862-053-00
    Billing NDC 65862005300
    Package 100 TABLET, FILM COATED in 1 BOTTLE (65862-053-00)
    Marketing Start Date 2006-12-20
    NDC Exclude Flag N
    Pricing Information N/A