DEA schedule
Is tofacitinib a controlled substance?
Federal schedule for tofacitinib from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Tofacitinib is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tofacitinib is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 60 prescription listings from 29 labelers, none with a DEA schedule |
| DEA controlled substances list | tofacitinib is not on the list |
Tofacitinib NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0069-1029 | XELJANZ | solution | 1 mg/mL | Pfizer Laboratories Div Pfizer Inc | None |
| 63539-029 | XELJANZ | solution | 1 mg/mL | U.S. Pharmaceuticals | None |
| 63539-501 | XELJANZ XR | tablet, extended release | 11 mg/1 | U.S. Pharmaceuticals | None |
| 63539-502 | XELJANZ XR | tablet, extended release | 22 mg/1 | U.S. Pharmaceuticals | None |
| 0069-1002 | XELJANZ | tablet, film coated | 10 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 63539-016 | XELJANZ | tablet, film coated | 10 mg/1 | U.S. Pharmaceuticals | None |
| 0069-1001 | XELJANZ | tablet, film coated | 5 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 63539-012 | XELJANZ | tablet, film coated | 5 mg/1 | U.S. Pharmaceuticals | None |
| 0069-0501 | XELJANZ XR | tablet, film coated, extended release | 11 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 0069-0502 | XELJANZ XR | tablet, film coated, extended release | 22 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 70095-008 | TOFACITINIB | solution | 1 mg/mL | Sun Pharmaceutical Industries, Inc. | None |
| 71085-099 | TOFACITINIB | solution | 1 mg/mL | IPG Pharmaceuticals, Inc | None |
| 71656-071 | Tofacitinib | solution | 1 mg/mL | Saptalis Pharmaceuticals, LLC. | None |
| 72205-121 | TOFACITINIB | solution | 1 mg/mL | Novadoz Pharmaceuticals LLC | None |
| 51991-963 | Tofacitinib | tablet | 10 mg/1 | Breckenridge Pharmaceutical, Inc. | None |
| 51991-329 | Tofacitinib | tablet | 5 mg/1 | Breckenridge Pharmaceutical, Inc. | None |
| 27241-270 | Tofacitinib | tablet, extended release | 11 mg/1 | Ajanta Pharma USA Inc. | None |
| 59651-685 | TOFACITINIB | tablet, extended release | 11 mg/1 | Aurobindo Pharma Limited | None |
| 72162-2684 | TOFACITINIB | tablet, extended release | 11 mg/1 | Bryant Ranch Prepack | None |
| 33342-542 | Tofacitinib | tablet, film coated | 10 mg/1 | Macleods Pharmaceuticals Limited | None |
| 42571-377 | TOFACITINIB | tablet, film coated | 10 mg/1 | Micro Labs Limited | None |
| 59651-460 | TOFACITINIB | tablet, film coated | 10 mg/1 | Aurobindo Pharma Limited | None |
| 60505-6264 | Tofacitinib | tablet, film coated | 10 mg/1 | Apotex Corp. | None |
| 70069-842 | TOFACITINIB | tablet, film coated | 10 mg/1 | Somerset Therapeutics, LLC | None |
| 70710-1589 | tofacitinib | tablet, film coated | 10 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1967 | tofacitinib | tablet, film coated | 10 mg/1 | Zydus Lifesciences Limited | None |
| 72205-140 | Tofacitinib | tablet, film coated | 10 mg/1 | Novadoz Pharmaceuticals LLC | None |
| 72865-367 | Tofacitinib | tablet, film coated | 10 mg/1 | XLCare Pharmaceuticals Inc | None |
| 73190-101 | Tofacitinib | tablet, film coated | 10 mg/1 | AvKARE | None |
| 84677-055 | Tofacitinib | tablet, film coated | 10 mg/1 | Golden State Medical Supply, Inc. | None |
| 33342-541 | Tofacitinib | tablet, film coated | 5 mg/1 | Macleods Pharmaceuticals Limited | None |
| 42571-268 | TOFACITINIB | tablet, film coated | 5 mg/1 | Micro Labs Limited | None |
| 59651-459 | TOFACITINIB | tablet, film coated | 5 mg/1 | Aurobindo Pharma Limited | None |
| 60505-6263 | Tofacitinib | tablet, film coated | 5 mg/1 | Apotex Corp. | None |
| 70069-841 | TOFACITINIB | tablet, film coated | 5 mg/1 | Somerset Therapeutics, LLC | None |
| 70710-1243 | tofacitinib | tablet, film coated | 5 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1821 | tofacitinib | tablet, film coated | 5 mg/1 | Zydus Lifesciences Limited | None |
| 72205-139 | Tofacitinib | tablet, film coated | 5 mg/1 | Novadoz Pharmaceuticals LLC | None |
| 72865-366 | Tofacitinib | tablet, film coated | 5 mg/1 | XLCare Pharmaceuticals Inc | None |
| 73190-100 | Tofacitinib | tablet, film coated | 5 mg/1 | AvKARE | None |
Showing 40 of 60 listings.
Questions
Is tofacitinib a controlled substance?
No. Tofacitinib is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tofacitinib is not on the DEA controlled substances list.
Is tofacitinib a narcotic?
No. Tofacitinib is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Janus Kinase Inhibitor.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Tofacitinib
- What is Tofacitinib used for?FDA label uses
- Generic for XeljanzFDA Orange Book
- Generic for Xeljanz XRFDA Orange Book
- What is Xeljanz used for?FDA label uses
- Is Xeljanz a controlled substance?Federal schedule
- Janus Kinase Inhibitors listFDA drug class
- Tofacitinib Medicare Part D coverageBy plan and state
- NDC 0069-0501Tofacitinib NDC record
- NDC 0069-0502Tofacitinib NDC record
- NDC 0069-1001Tofacitinib NDC record