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    NDC 42291-0078-10 Ezetimibe and Simvastatin 10; 10 mg/1; mg/1 Details

    Ezetimibe and Simvastatin 10; 10 mg/1; mg/1

    Ezetimibe and Simvastatin is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is EZETIMIBE; SIMVASTATIN.

    Product Information

    NDC 42291-0078
    Product ID 42291-078_0e8b3503-236f-af12-e063-6294a90af0c0
    Associated GPIs
    GCN Sequence Number 057859
    GCN Sequence Number Description ezetimibe/simvastatin TABLET 10 MG-10MG ORAL
    HIC3 M4M
    HIC3 Description ANTIHYPERLIP.HMG COA REDUCT INHIB-CHOLEST.AB.INHIB
    GCN 23121
    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; 10
    Active Ingredient Units mg/1; mg/1
    Substance Name EZETIMIBE; SIMVASTATIN
    Labeler Name AvKARE
    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 ANDA208831
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0078-10 (42291007810)

    NDC Package Code 42291-078-10
    Billing NDC 42291007810
    Package 1000 TABLET in 1 BOTTLE (42291-078-10)
    Marketing Start Date 2022-10-04
    NDC Exclude Flag N
    Pricing Information N/A