"0378-6167-05" National Drug Code (NDC)

Amlodipine Besylate/atorvastatin Calcium 500 TABLET, FILM COATED in 1 BOTTLE (0378-6167-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6167-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (0378-6167-05)
Product NDC0378-6167
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmlodipine Besylate/atorvastatin Calcium
Non-Proprietary NameAmlodipine Besylate And Atorvastatin Calcium
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20111130
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA021540
ManufacturerMylan Pharmaceuticals Inc.
Substance NameAMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Strength5; 80
Strength Unitmg/1; mg/1
Pharmacy ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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