Active ingredient
Tofacitinib
51 finished FDA listings contain Tofacitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOFACITINIB, TOFACITINIB CITRATE
- Dosage forms
- Solution, Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 24
- Strengths listed
- 1 mg/ml · 10 mg/1 · 11 mg/1 · 22 mg/1 · 5 mg/1
- Brand names in FDA listings
- Tofacitinib, Tofacitinib Solution, Tofacitinib Xr, Xeljanz, Xeljanz Xr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1357536
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 203214 | PF PRISM CV | 2012-11-06 | 4 |
| NDA 208246 | PFIZER | 2016-02-23 | 4 |
| NDA 213082 | PFIZER | 2020-09-25 | 2 |
| ANDA 214264 | ZYDUS PHARMS | 2021-08-19 | 4 |
| ANDA 209738 | MICRO LABS | 2023-03-13 | 2 |
| ANDA 209829 | ZYDUS PHARMS | 2023-03-14 | 4 |
| ANDA 216878 | HIKMA | 2023-09-25 | 1 |
| ANDA 218462 | AUROBINDO PHARMA LTD | 2024-06-03 | 1 |
| ANDA 218668 | DEXCEL | 2024-12-16 | 1 |
| ANDA 219542 | AJANTA PHARMA LTD | 2025-08-19 | 1 |
| ANDA 216001 | SINOTHERAPEUTICS INC | 2025-09-30 | 1 |
| ANDA 219442 | BIOCON PHARMA | 2025-11-17 | 1 |
| ANDA 215356 | AUROBINDO PHARMA LTD | 2026-06-03 | 2 |
| ANDA 220458 | APOTEX | 2026-06-03 | 2 |
| ANDA 219530 | MACLEODS PHARMS | 2026-06-03 | 2 |
| ANDA 209633 | BRECKENRIDGE | 2026-06-03 | 2 |
| ANDA 217299 | MSN | 2026-06-03 | 4 |
| ANDA 217298 | MSN | 2026-06-03 | 1 |
| ANDA 218407 | SUN PHARM INDS INC | 2026-06-03 | 1 |
| ANDA 218096 | APOTEX | 2026-06-03 | 4 |
| ANDA 220137 | SOMERSET THERAPS LLC | 2026-06-03 | 2 |
| ANDA 219370 | PHARMACO | 2026-06-09 | 1 |
| ANDA 219830 | ORIENT PHARMA | 2026-06-09 | 2 |
| ANDA 220972 | SCIEGEN PHARMS | 2026-06-25 | 2 |
Official labeling on DailyMed
- TOFACITINIB SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-09-02
- TOFACITINIB TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 3 · 2026-09-02
- TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.] · version 7 · 2026-08-24
- TOFACITINIB TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2026-08-17
- TOFACITINIB (TOFACITINIB CITRATE) TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 3 · 2026-08-14
- TOFACITINIB TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2026-08-10
- TOFACITINIB SOLUTION (TOFACITINIB) SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2026-08-10
- TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] · version 7 · 2026-08-10
- TOFACITINIB TABLET, FILM COATED [APOTEX CORP.] · version 3 · 2026-08-06
- TOFACITINIB SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2026-08-04
- TOFACITINIB TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 8 · 2026-08-03
- TOFACITINIB TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 5 · 2026-07-30
Showing the 12 most recent of 28 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.