"0078-0561-30" National Drug Code (NDC)

NDC Code	0078-0561-30
Package Description	30 BLISTER PACK in 1 CARTON (0078-0561-30) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC	0078-0561
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; VALSARTAN; HYDROCHLOROTHIAZIDE
Strength	10; 160; 12.5
Strength Unit	mg/1; mg/1; mg/1
Pharmacy Classes	Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]