DEA schedule
Is zileuton a controlled substance?
Federal schedule for zileuton from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Zileuton is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and zileuton is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 6 prescription listings from 6 labelers, none with a DEA schedule |
| DEA controlled substances list | zileuton is not on the list |
Zileuton NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 10122-901 | ZYFLO | tablet | 600 mg/1 | Chiesi USA, Inc. | None |
| 64980-206 | Zileuton | tablet, extended release | 600 mg/1 | Rising Pharma Holdings, Inc. | None |
| 31722-044 | Zileuton | tablet, film coated, extended release | 600 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 72603-246 | Zileuton | tablet, film coated, extended release | 600 mg/1 | NorthStar RxLLC | None |
| 51407-741 | Zileuton | tablet, multilayer, extended release | 600 mg/1 | Golden State Medical Supply, Inc. | None |
| 64380-189 | Zileuton | tablet, multilayer, extended release | 600 mg/1 | Strides Pharma Science Limited | None |
Questions
Is zileuton a controlled substance?
No. Zileuton is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and zileuton is not on the DEA controlled substances list.
Is zileuton a narcotic?
No. Zileuton is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is 5-Lipoxygenase 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.