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

NDC Code	0078-0563-15
Package Description	30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)
Product NDC	0078-0563
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Exforge Hct
Non-Proprietary Name	Amlodipine Valsartan And Hydrochlorothiazide
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20090404
Marketing Category Name	NDA
Application Number	NDA022314
Manufacturer	Novartis Pharmaceuticals Corporation
Substance Name	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Strength	10; 25; 320
Strength Unit	mg/1; mg/1; mg/1
Pharmacy Classes	Angiotensin 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]