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    NDC 71335-1905-07 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 Bryant Ranch Prepack. The primary component is SIMVASTATIN.

    Product Information

    NDC 71335-1905
    Product ID 71335-1905_4277e75a-7f3b-4f35-ae56-0bbe095586a5
    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 10
    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 ANDA078034
    Listing Certified Through 2023-12-31

    Package

    NDC 71335-1905-07 (71335190507)

    NDC Package Code 71335-1905-7
    Billing NDC 71335190507
    Package 10 TABLET, FILM COATED in 1 BOTTLE (71335-1905-7)
    Marketing Start Date 2021-12-29
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 4277e75a-7f3b-4f35-ae56-0bbe095586a5 Details

    Revised: 12/2021