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    NDC 68180-0482-03 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 Lupin Pharmaceuticals, Inc.. The primary component is SIMVASTATIN.

    Product Information

    NDC 68180-0482
    Product ID 68180-482_751a4a5d-986d-4dbe-a09f-2cf83466bf47
    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 5
    Active Ingredient Units mg/1
    Substance Name SIMVASTATIN
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078103
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0482-03 (68180048203)

    NDC Package Code 68180-482-03
    Billing NDC 68180048203
    Package 1000 TABLET, FILM COATED in 1 BOTTLE (68180-482-03)
    Marketing Start Date 2009-07-14
    NDC Exclude Flag N
    Pricing Information N/A