| NDC Code | 57297-772-02 |
| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE (57297-772-02) |
| Product NDC | 57297-772 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Amlodipine, Valsartan And Hydrochlorothiazide |
| Non-Proprietary Name | Amlodipine, Valsartan And Hydrochlorothiazide |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20150603 |
| Marketing Category Name | ANDA |
| Application Number | ANDA200797 |
| Manufacturer | LUPIN LIMITED |
| Substance Name | AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE |
| Strength | 10; 160; 12.5 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmacy Classes | Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS] |