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    NDC 31722-0510-01 Simvastatin 5 mg/1 Details

    Simvastatin 5 mg/1

    Simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Camber Pharmaceuticals, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 31722-0510
    Product ID 31722-510_00582961-060a-58b6-e063-6394a90aa25a
    Associated GPIs 39400075000310
    GCN Sequence Number 016576
    GCN Sequence Number Description simvastatin TABLET 5 MG ORAL
    HIC3 M4D
    HIC3 Description ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS)
    GCN 26531
    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 5
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name Camber Pharmaceuticals, Inc.
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA200895
    Listing Certified Through 2024-12-31

    Package

    NDC 31722-0510-01 (31722051001)

    NDC Package Code 31722-510-01
    Billing NDC 31722051001
    Package 100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01)
    Marketing Start Date 2014-12-09
    NDC Exclude Flag N
    Pricing Information N/A