"0078-0613-34" National Drug Code (NDC)

NDC Code	0078-0613-34
Package Description	90 TABLET, FILM COATED in 1 BOTTLE (0078-0613-34)
Product NDC	0078-0613
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Amturnide
Non-Proprietary Name	Aliskiren Hemifumarate And Amlodipine Besylate And Hydrochlorothiazide
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20101221
End Marketing Date	20151031
Marketing Category Name	NDA
Application Number	NDA200045
Manufacturer	Novartis Pharmaceuticals Corporation
Substance Name	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Strength	300; 10; 12.5
Strength Unit	mg/1; mg/1; mg/1
Pharmacy Classes	Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]