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    NDC 60505-3492-03 Amlodipine and Atorvastatin 5; 80 mg/1; mg/1 Details

    Amlodipine and Atorvastatin 5; 80 mg/1; mg/1

    Amlodipine and Atorvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE.

    Product Information

    NDC 60505-3492
    Product ID 60505-3492_a8614d7b-ff0d-a02c-983a-d0745908a702
    Associated GPIs 40992502150335
    GCN Sequence Number 053692
    GCN Sequence Number Description amlodipine/atorvastatin TABLET 5 MG-80 MG ORAL
    HIC3 M4I
    HIC3 Description ANTIHYPERLIPID- HMG-COA RI-CALCIUM CHANNEL BLOCKER
    GCN 21394
    HICL Sequence Number 025951
    HICL Sequence Number Description AMLODIPINE BESYLATE/ATORVASTATIN CALCIUM
    Brand/Generic Generic
    Proprietary Name Amlodipine and Atorvastatin
    Proprietary Name Suffix n/a
    Non-Proprietary Name Amlodipine and Atorvastatin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5; 80
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
    Labeler Name Apotex Corp.
    Pharmaceutical Class Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA205199
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-3492-03 (60505349203)

    NDC Package Code 60505-3492-3
    Billing NDC 60505349203
    Package 30 TABLET, FILM COATED in 1 BOTTLE (60505-3492-3)
    Marketing Start Date 2020-07-29
    NDC Exclude Flag N
    Pricing Information N/A