DEA schedule
Is Xeljanz a controlled substance?
Xeljanz contains tofacitinib. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Xeljanz (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 | 10 prescription listings from 2 labelers, none with a DEA schedule |
| DEA controlled substances list | tofacitinib is not on the list |
Xeljanz 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 |
Questions
Is Xeljanz a controlled substance?
No. Xeljanz (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 Xeljanz a narcotic?
No. Xeljanz (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 Xeljanz
- What is Xeljanz used for?FDA label uses
- Generic for XeljanzFDA Orange Book
- What is Tofacitinib used for?FDA label uses
- Is Tofacitinib a controlled substance?Federal schedule
- Generic for Xeljanz XRFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Xeljanz Medicare Part D coverageBy plan and state
- NDC 0069-0501Xeljanz NDC record
- NDC 0069-0502Xeljanz NDC record
- NDC 0069-1001Xeljanz NDC record