Irbesartan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Irbesartan.
| Product ID | 0955-1042_2985ab87-9e47-4328-9bc4-cca1972fca8b |
| NDC | 0955-1042 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Irbesartan |
| Generic Name | Irbesartan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-09-30 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA020757 |
| Labeler Name | Winthrop U.S. |
| Substance Name | IRBESARTAN |
| Active Ingredient Strength | 300 mg/1 |
| Pharm Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA020757 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-09-30 |
| Marketing End Date | 2019-08-08 |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA020757 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-30 |
| Marketing End Date | 2013-01-02 |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA020757 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-09-30 |
| Ingredient | Strength |
|---|---|
| IRBESARTAN | 300 mg/1 |
| SPL SET ID: | 8c5a4a2a-234e-4702-9ba0-844ea86ec8b9 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0250 | Irbesartan | Irbesartan |
| 0054-0251 | Irbesartan | Irbesartan |
| 0054-0252 | Irbesartan | Irbesartan |
| 0955-1040 | Irbesartan | irbesartan |
| 0955-1041 | Irbesartan | irbesartan |
| 0955-1042 | Irbesartan | irbesartan |
| 68084-217 | Irbesartan | Irbesartan |
| 68180-410 | Irbesartan | Irbesartan |
| 68180-412 | Irbesartan | Irbesartan |
| 68180-411 | Irbesartan | Irbesartan |
| 68382-300 | Irbesartan | Irbesartan |
| 68382-299 | Irbesartan | Irbesartan |
| 68382-301 | Irbesartan | Irbesartan |
| 69367-120 | Irbesartan | Irbesartan |
| 69367-121 | Irbesartan | Irbesartan |
| 69367-119 | Irbesartan | Irbesartan |
| 70518-1543 | Irbesartan | Irbesartan |
| 70518-1328 | Irbesartan | Irbesartan |
| 70518-1329 | Irbesartan | Irbesartan |
| 70518-1974 | IRBESARTAN | IRBESARTAN |
| 70518-1798 | Irbesartan | Irbesartan |
| 70518-1690 | Irbesartan | Irbesartan |
| 70771-1161 | Irbesartan | Irbesartan |
| 70771-1160 | Irbesartan | Irbesartan |
| 70771-1159 | Irbesartan | Irbesartan |
| 71335-0071 | Irbesartan | Irbesartan |
| 71205-082 | Irbesartan | Irbesartan |
| 71335-0423 | IRBESARTAN | IRBESARTAN |
| 29300-214 | Irbesartan | Irbesartan |
| 29300-213 | Irbesartan | Irbesartan |
| 27241-035 | Irbesartan | Irbesartan |
| 29300-212 | Irbesartan | Irbesartan |
| 27241-033 | Irbesartan | Irbesartan |
| 27241-036 | Irbesartan | Irbesartan |
| 31722-162 | Irbesartan | Irbesartan |
| 31722-160 | Irbesartan | Irbesartan |
| 31722-729 | Irbesartan | Irbesartan |
| 31722-730 | Irbesartan | Irbesartan |
| 33342-049 | Irbesartan | Irbesartan |
| 33342-047 | Irbesartan | Irbesartan |
| 33342-048 | Irbesartan | Irbesartan |
| 31722-161 | Irbesartan | Irbesartan |
| 31722-731 | Irbesartan | Irbesartan |
| 42658-122 | IRBESARTAN | IRBESARTAN |
| 42658-121 | IRBESARTAN | IRBESARTAN |
| 42658-123 | IRBESARTAN | IRBESARTAN |
| 43547-374 | Irbesartan | Irbesartan |
| 43547-375 | Irbesartan | Irbesartan |
| 43547-279 | Irbesartan | Irbesartan |
| 43547-277 | Irbesartan | Irbesartan |