| NDC Code | 0955-1046-90 |
|---|
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (0955-1046-90) |
|---|
| Product NDC | 0955-1046 |
|---|
| 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 | 20190930 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA020758 |
|---|
| Manufacturer | Winthrop U.S, a business of sanofi-aventis U.S. LLC |
|---|
| 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] |
|---|