| Product NDC: | 0078-0486 |
| Proprietary Name: | Tekturna |
| Non Proprietary Name: | aliskiren hemifumarate |
| Active Ingredient(s): | 300 mg/1 & nbsp; aliskiren hemifumarate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0486 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021985 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070305 |
| Package NDC: | 0078-0486-15 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0486-15) |
| NDC Code | 0078-0486-15 |
| Proprietary Name | Tekturna |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0486-15) |
| Product NDC | 0078-0486 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | aliskiren hemifumarate |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20070305 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | ALISKIREN HEMIFUMARATE |
| Strength Number | 300 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Renin Inhibitor [EPC],Renin Inhibitors [MoA] |