| Product NDC: | 0078-0562 |
| Proprietary Name: | Exforge HCT |
| Non Proprietary Name: | amlodipine valsartan and hydrochlorothiazide |
| Active Ingredient(s): | 10; 25; 160 mg/1; mg/1; mg/1 & nbsp; amlodipine valsartan and hydrochlorothiazide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0562 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022314 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090404 |
| Package NDC: | 0078-0562-34 |
| Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0562-34) |
| NDC Code | 0078-0562-34 |
| Proprietary Name | Exforge HCT |
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (0078-0562-34) |
| Product NDC | 0078-0562 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | amlodipine valsartan and hydrochlorothiazide |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20090404 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| Strength Number | 10; 25; 160 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmaceutical Classes | Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] |