Product NDC: | 0078-0611 |
Proprietary Name: | Amturnide |
Non Proprietary Name: | Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide |
Active Ingredient(s): | 300; 5; 12.5 mg/1; mg/1; mg/1 & nbsp; Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0611 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA200045 |
Marketing Category: | NDA |
Start Marketing Date: | 20101221 |
Package NDC: | 0078-0611-34 |
Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0611-34) |
NDC Code | 0078-0611-34 |
Proprietary Name | Amturnide |
Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0611-34) |
Product NDC | 0078-0611 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20101221 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE |
Strength Number | 300; 5; 12.5 |
Strength Unit | mg/1; mg/1; mg/1 |
Pharmaceutical 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] |