| 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: | 0078-0611-61 |
| Package Description: | 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0611-61) |
| NDC Code | 0078-0611-61 |
| Proprietary Name | Amturnide |
| Package Description | 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0611-61) |
| 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] |