Data / Drug companies / Irbesartan
Irbesartan: 27 companies and 83 products in the FDA NDC directory
Irbesartan is listed in the FDA National Drug Code Directory by 27 companies, with 83 products in commercial distribution. 81 of the products (97.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; tablet, film coated, and the newest product started marketing on March 25, 2026.
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- Companies listing it
- 27
- Products
- 83
- Generic (ANDA) products
- 81 (97.6%)
- Application numbers
- 14
- Routes
- Oral
- Brand names
- Avapro
- openFDA record search
- api.fda.gov
Companies that list irbesartan
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 7 | tablet | Generic drugs (ANDA) | June 13, 2016 |
| Camber Pharmaceuticals, Inc. | 6 | tablet | Generic drugs (ANDA) | October 6, 2016 |
| A-S Medication Solutions | 5 | tablet | Generic drugs (ANDA) | June 13, 2016 |
| Remedyrepack Inc. | 5 | tablet | Generic drugs (ANDA) | April 10, 2020 |
| Alembic Pharmaceuticals Inc. | 3 | tablet | Generic drugs (ANDA) | July 1, 2016 |
| Alembic Pharmaceuticals Limited | 3 | tablet | Generic drugs (ANDA) | July 1, 2016 |
| Amneal Pharmaceuticals LLC | 3 | tablet | Generic drugs (ANDA) | April 17, 2018 |
| Aurobindo Pharma Limited | 3 | tablet | Generic drugs (ANDA) | September 27, 2012 |
| AvKARE | 3 | tablet | Generic drugs (ANDA) | February 6, 2025 |
| Chartwell RX, LLC | 3 | tablet | Generic drugs (ANDA) | November 14, 2012 |
| Direct_Rx | 3 | tablet | Generic drugs (ANDA) | September 16, 2021 |
| Hisun Pharmaceuticals USA, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | April 15, 2017 |
| Jubilant Cadista Pharmaceuticals Inc. | 3 | tablet | Generic drugs (ANDA) | February 24, 2015 |
| Macleods Pharmaceuticals Limited | 3 | tablet | Generic drugs (ANDA) | September 27, 2012 |
| NorthStar RxLLC | 3 | tablet | Generic drugs (ANDA) | March 25, 2026 |
| Novadoz Pharmaceuticals LLC | 3 | tablet, film coated | Generic drugs (ANDA) | November 4, 2025 |
| Proficient Rx LP | 3 | tablet | Generic drugs (ANDA) | June 13, 2016 |
| ScieGen Pharmaceuticals, Inc. | 3 | tablet | Generic drugs (ANDA) | December 7, 2015 |
| Solco Healthcare US, LLC | 3 | tablet | Generic drugs (ANDA) | June 13, 2016 |
| Unichem Pharmaceuticals (USA), Inc. | 3 | tablet | Generic drugs (ANDA) | December 7, 2015 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | September 27, 2012 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | June 13, 2016 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | October 23, 2012 |
| Quality Care Products, LLC | 2 | tablet | Generic drugs (ANDA) | August 28, 2024 |
| Sanofi-Aventis U.S. LLC | 2 | tablet, film coated | New drug applications (NDA) | January 1, 2013 |
| Preferred Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | May 21, 2024 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | September 27, 2012 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 75 | 90.4% |
| Tablet, film coated | 8 | 9.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 81 | 97.6% |
| New drug applications (NDA) | 2 | 2.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Angiotensin 2 Receptor Blocker | 83 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.