Data / Drug companies / Mesalamine
Mesalamine: 41 companies and 64 products in the FDA NDC directory
Mesalamine is listed in the FDA National Drug Code Directory by 41 companies, with 64 products in commercial distribution. 55 of the products (85.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, delayed release; capsule, extended release; suppository, and the newest product started marketing on September 1, 2026.
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- Companies listing it
- 41
- Products
- 64
- Generic (ANDA) products
- 55 (85.9%)
- Application numbers
- 34
- Routes
- Oral, Rectal
- Brand names
- Pentasa, Lialda, Apriso, Canasa, Rowasa
- openFDA record search
- api.fda.gov
Companies that list mesalamine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| American Health Packaging | 4 | tablet, delayed release; capsule, extended release | Generic drugs (ANDA) | September 6, 2022 |
| Takeda Pharmaceuticals America, Inc. | 4 | tablet, delayed release; capsule | New drug applications (NDA) | August 29, 2017 |
| Zydus Lifesciences Limited | 4 | tablet, delayed release; suppository | Generic drugs (ANDA) | August 13, 2021 |
| Bryant Ranch Prepack | 3 | kit; suppository | Generic drugs (ANDA) | June 5, 2019 |
| Bryant Ranch Prepack | 3 | tablet, delayed release; suspension | Generic drugs (ANDA) | June 3, 2023 |
| Camber Pharmaceuticals, Inc. | 3 | capsule, extended release; tablet, delayed release | Generic drugs (ANDA) | August 13, 2025 |
| Padagis Israel Pharmaceuticals Ltd | 3 | kit; enema | Generic drugs (ANDA) | August 2, 2018 |
| Zydus Pharmaceuticals USA Inc. | 3 | tablet, delayed release; capsule, extended release | Generic drugs (ANDA) | August 13, 2021 |
| Golden State Medical Supply, Inc. | 2 | tablet, delayed release; capsule, extended release | Generic drugs (ANDA) | June 6, 2023 |
| Sandoz Inc | 2 | capsule, extended release | Generic drugs (ANDA) | July 21, 2026 |
| Sun Pharmaceutical Industries, Inc. | 2 | capsule, extended release; tablet, delayed release | Generic drugs (ANDA) | May 13, 2022 |
| Teva Pharmaceuticals USA, Inc. | 2 | capsule, extended release; capsule, delayed release | Authorized generics (NDA) | January 5, 2021 |
| Actavis Pharma, Inc. | 1 | suppository | Generic drugs (ANDA) | April 23, 2021 |
| Actavis Pharma, Inc. | 1 | tablet, delayed release | Generic drugs (ANDA) | March 26, 2018 |
| Alembic Pharmaceuticals Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | November 3, 2022 |
| Alembic Pharmaceuticals Limited | 1 | capsule, extended release | Generic drugs (ANDA) | November 3, 2022 |
| Allergan, Inc. | 1 | suppository | New drug applications (NDA) | January 5, 2001 |
| Amneal Pharmaceuticals LLC | 1 | tablet, delayed release | Generic drugs (ANDA) | February 19, 2025 |
| Ani Pharmaceuticals, Inc. | 1 | enema | Authorized generics (NDA) | May 13, 2016 |
| Ani Pharmaceuticals, Inc. | 1 | suspension | Generic drugs (ANDA) | May 14, 2026 |
| Ascend Laboratories, LLC | 1 | capsule, extended release | Generic drugs (ANDA) | July 16, 2021 |
| Aurobindo Pharma Limited | 1 | capsule, extended release | Generic drugs (ANDA) | March 31, 2023 |
| AvKARE | 1 | tablet, delayed release | Generic drugs (ANDA) | September 25, 2024 |
| AvPAK | 1 | capsule, extended release | Generic drugs (ANDA) | January 16, 2023 |
| Chartwell RX, LLC | 1 | tablet, delayed release | Generic drugs (ANDA) | June 3, 2023 |
| Encube Ethicals, Inc. | 1 | suspension | Generic drugs (ANDA) | June 1, 2023 |
| Ingenus Pharmaceuticals, LLC | 1 | capsule, extended release | Generic drugs (ANDA) | September 23, 2024 |
| KLM Laboratories Private Limited | 1 | suspension | Generic drugs (ANDA) | September 1, 2026 |
| Lannett Company, Inc. | 1 | tablet, delayed release | Generic drugs (ANDA) | June 3, 2023 |
| Major Pharmaceuticals | 1 | tablet, delayed release | Generic drugs (ANDA) | June 19, 2017 |
| Mylan Pharmaceuticals Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | November 26, 2019 |
| Nordic Pharma, Inc. | 1 | suppository | Generic drugs (ANDA) | June 24, 2019 |
| NorthStar Rx LLC | 1 | suppository | Generic drugs (ANDA) | August 25, 2021 |
| NorthStar RxLLC | 1 | tablet, delayed release | Generic drugs (ANDA) | December 1, 2024 |
| Nuvaila Limited | 1 | tablet, delayed release | Generic drugs (ANDA) | July 1, 2026 |
| Rising Pharma Holdings, Inc. | 1 | suppository | Generic drugs (ANDA) | April 14, 2025 |
| Salix Pharmaceuticals, Inc. | 1 | capsule, extended release | New drug applications (NDA) | October 31, 2008 |
| Teva Pharmaceuticals, Inc. | 1 | tablet, delayed release | Generic drugs (ANDA) | August 22, 2024 |
| Upsher-Smith Laboratories, LLC | 1 | capsule, extended release | Generic drugs (ANDA) | June 6, 2023 |
| Viatris Specialty LLC | 1 | suspension | New drug applications (NDA) | March 24, 2016 |
| Zydus Pharmaceuticals USA Inc. | 1 | suppository | Generic drugs (ANDA) | February 14, 2020 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, delayed release | 22 | 34.4% |
| Capsule, extended release | 18 | 28.1% |
| Suppository | 9 | 14.1% |
| Suspension | 5 | 7.8% |
| Kit | 4 | 6.2% |
| Enema | 2 | 3.1% |
| Capsule, delayed release | 2 | 3.1% |
| Capsule | 2 | 3.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 55 | 85.9% |
| New drug applications (NDA) | 6 | 9.4% |
| Authorized generics (NDA) | 3 | 4.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Aminosalicylate | 60 |
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.