| NDC Code | 60505-3603-9 |
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (60505-3603-9) |
| Product NDC | 60505-3603 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Irbesartan And Hydrochlorothiazide |
| Non-Proprietary Name | Irbesartan And Hydrochlorothiazide |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20121016 |
| Marketing Category Name | ANDA |
| Application Number | ANDA201505 |
| Manufacturer | Apotex Corp. |
| Substance Name | IRBESARTAN; HYDROCHLOROTHIAZIDE |
| Strength | 150; 12.5 |
| 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 [Chemical/Ingredient] |