Search by Drug Name or NDC

    NDC 42291-0081-50 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 AvKARE. The primary component is EZETIMIBE; SIMVASTATIN.

    Product Information

    NDC 42291-0081
    Product ID 42291-081_0e8b3503-236f-af12-e063-6294a90af0c0
    Associated GPIs
    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 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 42291-0081-50 (42291008150)

    NDC Package Code 42291-081-50
    Billing NDC 42291008150
    Package 500 TABLET in 1 BOTTLE (42291-081-50)
    Marketing Start Date 2022-10-04
    NDC Exclude Flag N
    Pricing Information N/A