"0378-1075-93" National Drug Code (NDC)

Telmisartan And Amlodipine 30 TABLET in 1 BOTTLE, PLASTIC (0378-1075-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1075-93
Package Description30 TABLET in 1 BOTTLE, PLASTIC (0378-1075-93)
Product NDC0378-1075
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
Strength5; 40
Strength Unitmg/1; mg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]

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