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    NDC 68462-0324-05 ezetimibe and simvastatin 10; 80 mg/1; mg/1 Details

    ezetimibe and simvastatin 10; 80 mg/1; mg/1

    ezetimibe and simvastatin is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is EZETIMIBE; SIMVASTATIN.

    Product Information

    NDC 68462-0324
    Product ID 68462-324_e4414c0e-2df1-4511-8149-3ad9e2cf99ad
    Associated GPIs 39994002300350
    GCN Sequence Number 057864
    GCN Sequence Number Description ezetimibe/simvastatin TABLET 10 MG-80MG ORAL
    HIC3 M4M
    HIC3 Description ANTIHYPERLIP.HMG COA REDUCT INHIB-CHOLEST.AB.INHIB
    GCN 23126
    HICL Sequence Number 026505
    HICL Sequence Number Description EZETIMIBE/SIMVASTATIN
    Brand/Generic Generic
    Proprietary Name ezetimibe and simvastatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name ezetimibe and simvastatin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10; 80
    Active Ingredient Units mg/1; mg/1
    Substance Name EZETIMIBE; SIMVASTATIN
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208699
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0324-05 (68462032405)

    NDC Package Code 68462-324-05
    Billing NDC 68462032405
    Package 500 TABLET in 1 BOTTLE (68462-324-05)
    Marketing Start Date 2019-06-27
    NDC Exclude Flag N
    Pricing Information N/A