Active ingredient
Zileuton
6 finished FDA listings contain Zileuton as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ZILEUTON
- Dosage forms
- Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release, Tablet, Multilayer, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 600 mg/1
- Brand names in FDA listings
- Zyflo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 40575
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 020471 | CHIESI | 1996-12-09 | 1 |
| ANDA 204929 | RISING | 2017-03-17 | 1 |
| ANDA 212670 | STRIDES PHARMA INTL | 2019-12-16 | 2 |
| ANDA 215742 | ANNORA PHARMA | 2022-10-11 | 2 |
Official labeling on DailyMed
- ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.] · version 33 · 2025-11-18
- ZILEUTON TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] · version 7 · 2024-05-24
- ZILEUTON (ZILEUTON) TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RXLLC] · version 1 · 2024-05-03
- ZILEUTON TABLET, MULTILAYER, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2023-03-21
- ZILEUTON (ZILEUTON) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2022-10-17
- ZILEUTON TABLET, MULTILAYER, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED] · version 2 · 2022-10-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.