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Amlodipine besylate/atorvastatin calcium - 0378-6167-05 - (AMLODIPINE BESYLATE and ATORVASTATIN CALCIUM)

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Drug Information of Amlodipine besylate/atorvastatin calcium

Product NDC: 0378-6167
Proprietary Name: Amlodipine besylate/atorvastatin calcium
Non Proprietary Name: AMLODIPINE BESYLATE and ATORVASTATIN CALCIUM
Active Ingredient(s): 5; 80    mg/1; mg/1 & nbsp;   AMLODIPINE BESYLATE and ATORVASTATIN CALCIUM
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Amlodipine besylate/atorvastatin calcium

Product NDC: 0378-6167
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021540
Marketing Category: NDA AUTHORIZED GENERIC
Start Marketing Date: 20111130

Package Information of Amlodipine besylate/atorvastatin calcium

Package NDC: 0378-6167-05
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE (0378-6167-05)

NDC Information of Amlodipine besylate/atorvastatin calcium

NDC Code 0378-6167-05
Proprietary Name Amlodipine besylate/atorvastatin calcium
Package Description 500 TABLET, FILM COATED in 1 BOTTLE (0378-6167-05)
Product NDC 0378-6167
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name AMLODIPINE BESYLATE and ATORVASTATIN CALCIUM
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20111130
Marketing Category Name NDA AUTHORIZED GENERIC
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Strength Number 5; 80
Strength Unit mg/1; mg/1
Pharmaceutical Classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Complete Information of Amlodipine besylate/atorvastatin calcium


General Information