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    NDC 63629-7421-01 simvastatin 5 mg/1 Details

    simvastatin 5 mg/1

    simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is SIMVASTATIN.

    Product Information

    NDC 63629-7421
    Product ID 63629-7421_1b2f36d9-7620-43a7-8071-7c057711bf61
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 5
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name Bryant Ranch Prepack
    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 63629-7421-01 (63629742101)

    NDC Package Code 63629-7421-1
    Billing NDC 63629742101
    Package 30 TABLET, FILM COATED in 1 BOTTLE (63629-7421-1)
    Marketing Start Date 2018-04-04
    NDC Exclude Flag N
    Pricing Information N/A