Medicine
Febuxostat 80 mg oral film
Febuxostat 80 mg oral film is a generic prescription medicine for oral use, 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 at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Febuxostat
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Oral film
- Route
- Oral
- Packs
- 30 films, 90 films, 500 films
- Manufacturer
- Macleods PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M04AA03 Febuxostat
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 April 2019
- Identifiers
- RxCUI 834235, 834241DailyMed set ID 77875ed1-049e-421b-a8d5-569b4af4a1b5NDC 33342-275Application ANDA207293
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 |
|---|---|---|---|
| 30 film in 1 bottle | 33342-275-07 | Macleods PharmaceuticalsIndia | 4 April 2019 |
| 90 film in 1 bottle | 33342-275-10 | Macleods PharmaceuticalsIndia | 4 April 2019 |
| 500 film in 1 bottle | 33342-275-15 | Macleods PharmaceuticalsIndia | 4 April 2019 |
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.
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 Febuxostat
Clinical summary
Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, among other approved uses. MedsAcross supplies Febuxostat 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 FebuxostatFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ULORIC prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Adenuric: European public assessment report (EPAR) · European Medicines Agency
- Febuxostat Krka: European public assessment report (EPAR) · European Medicines Agency
Need Febuxostat 80 mg oral film 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.