Medicine
Febuxostat 80 mg tablet
Febuxostat 80 mg tablet is a generic prescription medicine for oral use, made by 17 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 at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Febuxostat
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 100 tablets, 30 tablets and 49 more
- Manufacturers
- Alembic PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaNovadoz PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndia17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° 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
- 1 July 2019
- Identifiers
- RxCUI 834235, 834241DailyMed set ID d1969ea8-5178-42ee-97fc-feee8595e677, ad40e0f6-850c-429a-87fc-f1eb2361e962, 154ad94e-b775-4a10-ab0f-2874a0782db9 +15NDC 72205-029, 16714-060, 67877-669 +15Application ANDA210461, ANDA205467, ANDA212924 +8
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
A sample of 40 packs from 17 labelers. The register lists 52 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, coated in 1 carton | 46708-191-06 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 100 tablet, coated in 1 carton | 46708-191-10 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 30 tablet, coated in 1 bottle | 46708-191-30 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 100 tablet, coated in 1 bottle | 46708-191-31 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 1000 tablet, coated in 1 bottle | 46708-191-91 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 60 tablet, coated in 1 carton | 62332-191-06 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 100 tablet, coated in 1 carton | 62332-191-10 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 30 tablet, coated in 1 bottle | 62332-191-30 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 100 tablet, coated in 1 bottle | 62332-191-31 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 1000 tablet, coated in 1 bottle | 62332-191-91 | Alembic PharmaceuticalsIndia | 1 July 2019 |
| 100 tablet, film coated in 1 bottle | 67877-669-01 | Ascend LaboratoriesIndia | 8 December 2021 |
| 1000 tablet, film coated in 1 bottle | 67877-669-10 | Ascend LaboratoriesIndia | 8 December 2021 |
| 30 tablet, film coated in 1 bottle | 67877-669-30 | Ascend LaboratoriesIndia | 8 December 2021 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-669-38 | Ascend LaboratoriesIndia | 8 December 2021 |
| 100 tablet in 1 bottle | 59651-114-01 | Aurobindo PharmaIndia | 25 October 2023 |
| 500 tablet in 1 bottle | 59651-114-05 | Aurobindo PharmaIndia | 25 October 2023 |
| 30 tablet in 1 bottle | 59651-114-30 | Aurobindo PharmaIndia | 25 October 2023 |
| 90 tablet in 1 bottle | 59651-114-90 | Aurobindo PharmaIndia | 25 October 2023 |
| 100 tablet in 1 bottle | 55111-797-01 | Dr. Reddy's LaboratoriesIndia | 25 November 2020 |
| 500 tablet in 1 bottle | 55111-797-05 | Dr. Reddy's LaboratoriesIndia | 25 November 2020 |
| 30 tablet in 1 bottle | 55111-797-30 | Dr. Reddy's LaboratoriesIndia | 25 November 2020 |
| 90 tablet in 1 bottle | 55111-797-90 | Dr. Reddy's LaboratoriesIndia | 25 November 2020 |
| 30 tablet, film coated in 1 bottle | 72205-029-30 | Novadoz PharmaceuticalsIndia | 30 December 2019 |
| 90 tablet, film coated in 1 bottle | 72205-029-90 | Novadoz PharmaceuticalsIndia | 20 February 2026 |
| 100 tablet, film coated in 1 bottle | 72205-029-91 | Novadoz PharmaceuticalsIndia | 30 December 2019 |
| 1000 tablet, film coated in 1 bottle | 72205-029-99 | Novadoz PharmaceuticalsIndia | 30 December 2019 |
| 1000 tablet, film coated in 1 bottle | 47335-722-18 | Sun Pharmaceutical IndustriesIndia | 5 July 2019 |
| 30 tablet, film coated in 1 bottle | 47335-722-83 | Sun Pharmaceutical IndustriesIndia | 5 July 2019 |
| 100 tablet, film coated in 1 bottle | 47335-722-88 | Sun Pharmaceutical IndustriesIndia | 5 July 2019 |
| 100 tablet in 1 bottle | 72578-137-01 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 500 tablet in 1 bottle | 72578-137-05 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 30 tablet in 1 bottle | 72578-137-06 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 1000 tablet in 1 bottle | 72578-137-10 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 90 tablet in 1 bottle | 72578-137-16 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 72578-137-77 | Viona PharmaceuticalsIndia | 31 March 2023 |
| 1000 tablet in 1 bottle | 70771-1553-0 | Zydus LifesciencesIndia | 31 March 2023 |
| 100 tablet in 1 bottle | 70771-1553-1 | Zydus LifesciencesIndia | 31 March 2023 |
| 30 tablet in 1 bottle | 70771-1553-3 | Zydus LifesciencesIndia | 31 March 2023 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1553-4 | Zydus LifesciencesIndia | 31 March 2023 |
| 500 tablet in 1 bottle | 70771-1553-5 | Zydus LifesciencesIndia | 31 March 2023 |
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
Alternatives
Other makers and brands of Febuxostat 80 mg tablet.
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 tablet for your hospital or patient?
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