Zyflo 600 mg tablet is a prescription medicine containing Zileuton for oral use, marketed by Chiesi, 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 tablets at controlled room temperature between 20˚-25˚C, (68˚-77˚F)…
Key facts
- Active ingredient (INN)
- Zileuton
- Brand
- Zyflo
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets
- Marketing authorisation holder
- Chiesi
- Manufacturer
- Chiesi
- Origin register
- US FDA, United States
- Storage
- Store tablets at controlled room temperature between 20˚-25˚C, (68˚-77˚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
- 6 December 1996
- Identifiers
- RxCUI 199904, 211777DailyMed set ID aee65202-fddb-497f-9f11-17cc727cb157NDC 10122-901Application NDA020471
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet in 1 bottle | 10122-901-12 | Chiesi | 6 December 1996 |
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 Zyflo 600 mg 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.