Drug
Who makes zileuton?
6 companies list zileuton as a human prescription drug, including under the names ZYFLO. Forms: tablet; tablet, extended release; tablet, film coated, extended release; tablet, multilayer, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing zileuton
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Strides Pharma Science LimitedIndia | tablet, multilayer, extended release | ANDAANDA212670 | 1 | 5 |
| Camber Pharmaceuticals, Inc.United States | tablet, film coated, extended release | ANDAANDA215742 | 1 | 1 |
| Chiesi USA, Inc.Italy | tablet | NDANDA020471 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, multilayer, extended release | ANDAANDA212670 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, extended release | ANDAANDA204929 | 1 | 1 |
| NorthStar RxLLC | tablet, film coated, extended release | ANDAANDA215742 | 1 | 0 |
Bulk ingredient listings
- Apicore US LLCIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Erregierre SpAItaly · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
Enquiry
Common questions
- Who makes zileuton?
- 6 companies list zileuton as a human prescription drug in the openFDA NDC Directory, led by Strides Pharma Science Limited, Camber Pharmaceuticals, Inc., Chiesi USA, Inc., Golden State Medical Supply Inc., Rising Pharma Holdings, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ZYFLO?
- 5 companies list zileuton under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies zileuton active ingredient?
- 8 companies list zileuton as a bulk ingredient, including Apicore US LLC, Emcure Pharmaceuticals Limited, Erregierre SpA, MSN Laboratories Private Limited,.