| NDC Code | 0054-0255-22 |
| Package Description | 90 TABLET in 1 BOTTLE (0054-0255-22) |
| Product NDC | 0054-0255 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Irbesartan And Hydrochlorothiazide |
| Non-Proprietary Name | Irbesartan And Hydrochlorothiazide |
| Dosage Form | TABLET |
| Usage | ORAL |
| Start Marketing Date | 20121015 |
| Marketing Category Name | ANDA |
| Application Number | ANDA090351 |
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
| Substance Name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
| Strength | 12.5; 300 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] |