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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.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Pfizer Laboratories Div Pfizer Inc5tablet, film coated, extended release; tablet, film coatedNew drug applications (NDA)February 8, 2021
U.S. Pharmaceuticals5tablet, film coated; tablet, extended releaseNew drug applications (NDA)February 8, 2021
Zydus Lifesciences Limited4tablet, film coated; tablet, film coated, extended releaseGeneric drugs (ANDA)June 5, 2026
Zydus Pharmaceuticals USA Inc.4tablet, film coated; tablet, film coated, extended releaseGeneric drugs (ANDA)June 5, 2026
Apotex Corp.3tablet, film coated; tablet, film coated, extended releaseGeneric drugs (ANDA)June 3, 2026
Aurobindo Pharma Limited3tablet, film coated; tablet, extended releaseGeneric drugs (ANDA)June 3, 2026
AvKARE3tablet, film coated; tablet, film coated, extended releaseGeneric drugs (ANDA)July 23, 2026
Novadoz Pharmaceuticals LLC3tablet, film coated; solutionGeneric drugs (ANDA)June 3, 2026
Golden State Medical Supply, Inc.2tablet, film coatedGeneric drugs (ANDA)June 1, 2026
Macleods Pharmaceuticals Limited2tablet, film coatedGeneric drugs (ANDA)June 3, 2026
Micro Labs Limited2tablet, film coatedGeneric drugs (ANDA)June 8, 2026
Somerset Therapeutics, LLC2tablet, film coatedGeneric drugs (ANDA)June 3, 2026
XLCare Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)October 9, 2026
Ajanta Pharma USA Inc.1tablet, extended releaseGeneric drugs (ANDA)June 3, 2026
Biocon Pharma Inc.1tablet, film coated, extended releaseGeneric drugs (ANDA)June 3, 2026
Bryant Ranch Prepack1tablet, extended releaseGeneric drugs (ANDA)June 3, 2026
Edenbridge Pharmaceuticals LLC.1tablet, film coated, extended releaseGeneric drugs (ANDA)June 3, 2026
Exelan Pharmaceuticals Inc.1tablet, film coated, extended releaseGeneric drugs (ANDA)June 10, 2026
Hikma Pharmaceuticals USA Inc.1solutionGeneric drugs (ANDA)June 3, 2026
Ipg Pharmaceuticals, Inc.1solutionGeneric drugs (ANDA)June 15, 2026
Orient Pharma Co., Ltd.1tablet, film coated, extended releaseGeneric drugs (ANDA)June 10, 2026
Saptalis Pharmaceuticals, LLC.1solutionGeneric drugs (ANDA)August 20, 2026
Sun Pharmaceutical Industries, Inc.1solutionGeneric drugs (ANDA)June 3, 2026

Dosage forms

Dosage formProductsShare
Tablet, film coated2652%
Tablet, film coated, extended release1224%
Solution714%
Tablet, extended release510%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)4080%
New drug applications (NDA)1020%

Pharmacologic classes

ClassProducts
Janus Kinase Inhibitor50

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.