Data / Drug companies / Tofacitinib
Tofacitinib: 23 companies and 50 products in the FDA NDC directory
Tofacitinib is listed in the FDA National Drug Code Directory by 23 companies, with 50 products in commercial distribution. 40 of the products (80.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, film coated, extended release; solution, and the newest product started marketing on October 9, 2026.
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- Companies listing it
- 23
- Products
- 50
- Generic (ANDA) products
- 40 (80.0%)
- Application numbers
- 22
- Routes
- Oral
- Brand names
- Xeljanz, Xeljanz XR
- openFDA record search
- api.fda.gov
Companies that list tofacitinib
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 5 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | February 8, 2021 |
| U.S. Pharmaceuticals | 5 | tablet, film coated; tablet, extended release | New drug applications (NDA) | February 8, 2021 |
| Zydus Lifesciences Limited | 4 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | June 5, 2026 |
| Zydus Pharmaceuticals USA Inc. | 4 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | June 5, 2026 |
| Apotex Corp. | 3 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | June 3, 2026 |
| Aurobindo Pharma Limited | 3 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | June 3, 2026 |
| AvKARE | 3 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | July 23, 2026 |
| Novadoz Pharmaceuticals LLC | 3 | tablet, film coated; solution | Generic drugs (ANDA) | June 3, 2026 |
| Golden State Medical Supply, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | June 1, 2026 |
| Macleods Pharmaceuticals Limited | 2 | tablet, film coated | Generic drugs (ANDA) | June 3, 2026 |
| Micro Labs Limited | 2 | tablet, film coated | Generic drugs (ANDA) | June 8, 2026 |
| Somerset Therapeutics, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | June 3, 2026 |
| XLCare Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | October 9, 2026 |
| Ajanta Pharma USA Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | June 3, 2026 |
| Biocon Pharma Inc. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | June 3, 2026 |
| Bryant Ranch Prepack | 1 | tablet, extended release | Generic drugs (ANDA) | June 3, 2026 |
| Edenbridge Pharmaceuticals LLC. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | June 3, 2026 |
| Exelan Pharmaceuticals Inc. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | June 10, 2026 |
| Hikma Pharmaceuticals USA Inc. | 1 | solution | Generic drugs (ANDA) | June 3, 2026 |
| Ipg Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | June 15, 2026 |
| Orient Pharma Co., Ltd. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | June 10, 2026 |
| Saptalis Pharmaceuticals, LLC. | 1 | solution | Generic drugs (ANDA) | August 20, 2026 |
| Sun Pharmaceutical Industries, Inc. | 1 | solution | Generic drugs (ANDA) | June 3, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 26 | 52% |
| Tablet, film coated, extended release | 12 | 24% |
| Solution | 7 | 14% |
| Tablet, extended release | 5 | 10% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 40 | 80% |
| New drug applications (NDA) | 10 | 20% |
Pharmacologic classes
| Class | Products |
|---|---|
| Janus Kinase Inhibitor | 50 |
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.