Medicine
Leflunomide 20 mg tablet
Leflunomide 20 mg tablet is a generic prescription medicine for oral use, made by 14 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 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Leflunomide
- Brand
- Sold under the generic name
- Strength
- 20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 60 tablets and 32 more
- Manufacturers
- Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaAvet PharmaceuticalsIndiaAurobindo PharmaIndiaLupinIndiaBryant Ranch PrepackApotexA-S Medication SolutionsAvKAREAvPAK
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AK01 Leflunomide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 September 2005
- Identifiers
- RxCUI 205285, 205284DailyMed set ID af4079af-c127-476e-a2b3-53b438dc9da4, 8b365514-c859-ff93-e053-2a95a90ac698, af836cd0-da42-772e-e053-2995a90ac103 +17NDC 71335-2403, 42291-421, 50268-478 +17Application ANDA212308, ANDA077090, ANDA091369 +5
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 46708-437-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 46708-437-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 60 tablet in 1 bottle | 46708-437-60 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet in 1 bottle | 46708-437-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 30 tablet in 1 bottle | 62332-062-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 62332-062-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 60 tablet in 1 bottle | 62332-062-60 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet in 1 bottle | 62332-062-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet, film coated in 1 bottle | 70710-1158-1 | Zydus LifesciencesIndia | 26 April 2019 |
| 30 tablet, film coated in 1 bottle | 70710-1158-3 | Zydus LifesciencesIndia | 26 April 2019 |
| 500 tablet, film coated in 1 bottle | 70710-1158-5 | Zydus LifesciencesIndia | 26 April 2019 |
| 100 tablet, film coated in 1 bottle | 70771-1492-1 | Zydus LifesciencesIndia | 26 April 2019 |
| 30 tablet, film coated in 1 bottle | 70771-1492-3 | Zydus LifesciencesIndia | 26 April 2019 |
| 500 tablet, film coated in 1 bottle | 70771-1492-5 | Zydus LifesciencesIndia | 26 April 2019 |
| 30 tablet, film coated in 1 bottle | 59651-349-30 | Aurobindo PharmaIndia | 29 March 2021 |
| 30 tablet in 1 bottle | 23155-044-03 | Avet PharmaceuticalsIndia | 29 October 2009 |
| 500 tablet in 1 bottle | 23155-044-05 | Avet PharmaceuticalsIndia | 29 October 2009 |
| 30 tablet, film coated in 1 bottle | 70748-130-06 | LupinIndia | 31 August 2020 |
| 30 tablet in 1 bottle | 60505-2503-1 | Apotex | 13 September 2005 |
| 100 tablet in 1 bottle | 60505-2503-2 | Apotex | 13 September 2005 |
| 1000 tablet in 1 bottle | 60505-2503-3 | Apotex | 13 September 2005 |
| 30 tablet, film coated in 1 bottle | 35573-448-30 | Burel Pharmaceuticals | 3 January 2022 |
| 30 tablet in 1 bottle | 62135-794-30 | Chartwell RX | 26 October 2023 |
| 30 tablet in 1 bottle | 10702-278-03 | KVK-Tech | 23 July 2020 |
| 30 tablet, film coated in 1 bottle | 71335-2256-1 | Bryant Ranch Prepack | 25 September 2023 |
| 90 tablet, film coated in 1 bottle | 71335-2256-2 | Bryant Ranch Prepack | 6 September 2024 |
| 30 tablet, film coated in 1 bottle | 71335-2403-1 | Bryant Ranch Prepack | 12 August 2024 |
| 90 tablet, film coated in 1 bottle | 71335-2403-2 | Bryant Ranch Prepack | 24 May 2024 |
| 30 tablet in 1 bottle | 71335-2832-1 | Bryant Ranch Prepack | 22 October 2025 |
| 30 tablet in 1 bottle | 72162-2410-3 | Bryant Ranch Prepack | 29 October 2009 |
| 30 tablet, film coated in 1 bottle | 50090-5992-0 | A-S Medication Solutions | 10 June 2022 |
| 30 tablet, film coated in 1 bottle | 50090-7537-0 | A-S Medication Solutions | 9 April 2025 |
| 30 tablet in 1 bottle | 42291-421-30 | AvKARE | 13 June 2019 |
| 50 blister pack in 1 box / 1 tablet in 1 blister pack | 50268-478-15 | AvPAK | 17 September 2020 |
| 90 tablet, film coated in 1 bottle | 68071-3764-9 | NuCare Pharmaceuticals | 9 January 2025 |
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 Leflunomide 20 mg tablet.
Other strengths and forms of Leflunomide
Clinical summary
Leflunomide is an antirheumatic agent indicated for the treatment of adults with active rheumatoid arthritis (RA). It is available as tablets for oral use. MedsAcross supplies Leflunomide 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 LeflunomideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Arava prescribing information (sanofi-aventis) · U.S. National Library of Medicine, DailyMed
- Arava: European public assessment report (EPAR) · European Medicines Agency
- Leflunomide Zentiva (previously Leflunomide Winthrop): European public assessment report (EPAR) · European Medicines Agency
Need Leflunomide 20 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.