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    NDC 61919-0688-90 SIMVASTATIN 10 mg/1 Details

    SIMVASTATIN 10 mg/1

    SIMVASTATIN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DIRECT RX. The primary component is SIMVASTATIN.

    Product Information

    NDC 61919-0688
    Product ID 61919-688_f215afbc-93ab-1803-e053-2a95a90a4fe1
    Associated GPIs 39400075000320
    GCN Sequence Number 016577
    GCN Sequence Number Description simvastatin TABLET 10 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 26532
    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 10
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name DIRECT RX
    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 61919-0688-90 (61919068890)

    NDC Package Code 61919-688-90
    Billing NDC 61919068890
    Package 90 TABLET, FILM COATED in 1 BOTTLE (61919-688-90)
    Marketing Start Date 2021-09-08
    NDC Exclude Flag N
    Pricing Information N/A