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    NDC 00378-4516-93 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 Mylan Pharmaceuticals Inc.. The primary component is AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE.

    Product Information

    NDC 00378-4516
    Product ID 0378-4516_f478482e-05f2-46d6-87d2-8f36c5146d85
    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 Mylan Pharmaceuticals Inc.
    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 ANDA200465
    Listing Certified Through 2024-12-31

    Package

    NDC 00378-4516-93 (00378451693)

    NDC Package Code 0378-4516-93
    Billing NDC 00378451693
    Package 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4516-93)
    Marketing Start Date 2014-10-10
    NDC Exclude Flag N
    Pricing Information N/A