| NDC Code | 64380-198-01 |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (64380-198-01) |
| Product NDC | 64380-198 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Amlodipine, Valsartan, Hydrochlorothiazide |
| Non-Proprietary Name | Amlodipine Besylate Valsartan Hydrochlorothiazide |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20220627 |
| Marketing Category Name | ANDA |
| Application Number | ANDA201087 |
| Manufacturer | Strides Pharma Science Limited |
| Substance Name | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
| Strength | 5; 25; 160 |
| Strength Unit | mg/1; mg/1; mg/1 |
| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] |