Data / Drug companies / Sulfasalazine
Sulfasalazine: 10 companies and 14 products in the FDA NDC directory
Sulfasalazine is listed in the FDA National Drug Code Directory by 10 companies, with 14 products in commercial distribution. 6 of the products (42.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; tablet, delayed release, and the newest product started marketing on December 11, 2025.
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- Companies listing it
- 10
- Products
- 14
- Generic (ANDA) products
- 6 (42.9%)
- Application numbers
- 6
- Routes
- Oral
- Brand names
- Azulfidine EN-tabs, Azulfidine
- openFDA record search
- api.fda.gov
Companies that list sulfasalazine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 2 | tablet | Authorized generics (NDA) | July 1, 2003 |
| Mylan Pharmaceuticals Inc. | 2 | tablet, delayed release; tablet | Authorized generics (NDA) | May 5, 2005 |
| Pfizer Laboratories Div Pfizer Inc | 2 | tablet, delayed release; tablet | New drug applications (NDA) | June 20, 1950 |
| Sunrise Pharmaceutical, Inc. | 2 | tablet, delayed release; tablet | Generic drugs (ANDA) | December 11, 2025 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet | Authorized generics (NDA) | July 1, 2003 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | December 15, 2022 |
| Chartwell RX, LLC | 1 | tablet | Generic drugs (ANDA) | November 12, 1973 |
| Remedyrepack Inc. | 1 | tablet | Authorized generics (NDA) | January 28, 2019 |
| Rising Pharma Holdings, Inc. | 1 | tablet | Generic drugs (ANDA) | November 4, 2025 |
| Teva Pharmaceuticals USA, Inc. | 1 | tablet | Generic drugs (ANDA) | December 15, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 11 | 78.6% |
| Tablet, delayed release | 3 | 21.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 6 | 42.9% |
| Authorized generics (NDA) | 6 | 42.9% |
| New drug applications (NDA) | 2 | 14.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Aminosalicylate | 14 |
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.