"0378-1078-05" National Drug Code (NDC)

Telmisartan And Amlodipine 500 TABLET in 1 BOTTLE, PLASTIC (0378-1078-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1078-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-1078-05)
Product NDC0378-1078
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTelmisartan And Amlodipine
Non-Proprietary NameTelmisartan And Amlodipine
Dosage FormTABLET
UsageORAL
Start Marketing Date20140919
Marketing Category NameANDA
Application NumberANDA202516
ManufacturerMylan Pharmaceuticals Inc.
Substance NameAMLODIPINE BESYLATE; TELMISARTAN
Strength10; 80
Strength Unitmg/1; mg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]

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