"0078-0563-15" National Drug Code (NDC)

Exforge Hct 30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)
(Novartis Pharmaceuticals Corporation)

NDC Code0078-0563-15
Package Description30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)
Product NDC0078-0563
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameExforge Hct
Non-Proprietary NameAmlodipine Valsartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090404
Marketing Category NameNDA
Application NumberNDA022314
ManufacturerNovartis Pharmaceuticals Corporation
Substance NameAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Strength10; 25; 320
Strength Unitmg/1; mg/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], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]

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