Medicine
Zileuton 600 mg extended-release tablet
Zileuton 600 mg extended-release tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store between 20 to 25°C (68 to 77°F), excursions permitted to 15-30°C (59 to…
Key facts
- Active ingredient (INN)
- Zileuton
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 120 tablets and 2 more
- Manufacturers
- Camber PharmaceuticalsIndiaStrides PharmaIndiaGolden State Medical SupplyNorthStar RxLLCRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store between 20 to 25°C (68 to 77°F), excursions permitted to 15-30°C (59 to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 March 2017
- Identifiers
- RxCUI 730834DailyMed set ID fd382540-b390-4e86-a94a-988ea89c93a8, f7573809-7741-04c9-e053-6294a90ab193, bc29c998-1324-46aa-8386-e5b2fc9e0b16 +2NDC 64980-206, 51407-741, 72603-246 +2Application ANDA204929, ANDA212670, ANDA215742
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet, film coated, extended release in 1 bottle | 31722-044-12 | Camber PharmaceuticalsIndia | 11 October 2022 |
| 120 tablet, multilayer, extended release in 1 bottle | 64380-189-01 | Strides PharmaIndia | 15 October 2022 |
| 120 tablet, extended release in 1 bottle | 64980-206-12 | Rising Pharma Holdings | 21 March 2017 |
| 120 tablet, multilayer, extended release in 1 bottle | 51407-741-12 | Golden State Medical Supply | 19 January 2023 |
| 120 tablet, film coated, extended release in 1 bottle | 72603-246-01 | NorthStar RxLLC | 1 May 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 9 December 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Zileuton
Clinical summary
Zileuton is a 5-lipoxygenase inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Zileuton for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ZileutonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZYFLO prescribing information (Chiesi) · U.S. National Library of Medicine, DailyMed
Need Zileuton 600 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.