Medicine
Azathioprine 50 mg tablet
Azathioprine 50 mg tablet is a generic prescription medicine for oral use, made by 12 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. PROTECT FROM MOISTURE.
Key facts
- Active ingredient (INN)
- Azathioprine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 17 more
- Manufacturers
- Ascend LaboratoriesIndiaZydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaAmneal Pharmaceuticals NYNuCare Pharmaceuticals,IncAmerican Health PackagingAphena Pharma Solutions - TennesseeAvKAREGolden State Medical SupplyPD-Rx Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT. PROTECT FROM MOISTURE.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AX01 Azathioprine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 June 1999
- Identifiers
- RxCUI 197388, 359228, 359229 +1DailyMed set ID 59f3219f-898f-4d05-a430-c2b3f5255af1, 2f994aed-f8e7-4967-a167-b22b783b4192, d65bc662-2ae8-4ddb-acc8-f616e72e6140 +12NDC 60219-1076, 71610-124, 65841-602 +12Application ANDA074069, ANDA077621, ANDA208687 +2
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 65841-602-01 | Zydus LifesciencesIndia | 11 July 2007 |
| 500 tablet in 1 bottle | 65841-602-05 | Zydus LifesciencesIndia | 11 July 2007 |
| 100 tablet in 1 bottle | 68382-003-01 | Zydus LifesciencesIndia | 11 July 2007 |
| 500 tablet in 1 bottle | 68382-003-05 | Zydus LifesciencesIndia | 11 July 2007 |
| 100 tablet in 1 bottle | 67877-493-01 | Ascend LaboratoriesIndia | 29 March 2020 |
| 500 tablet in 1 bottle | 67877-493-05 | Ascend LaboratoriesIndia | 29 March 2020 |
| 1000 tablet in 1 bottle | 67877-493-10 | Ascend LaboratoriesIndia | 29 March 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-493-38 | Ascend LaboratoriesIndia | 29 March 2020 |
| 100 tablet in 1 bottle | 68462-502-01 | Glenmark PharmaceuticalsIndia | 1 August 1999 |
| 100 tablet in 1 bottle | 60219-1076-1 | Amneal Pharmaceuticals NY | 2 February 2015 |
| 100 tablet in 1 bottle | 69238-1076-1 | Amneal Pharmaceuticals NY | 2 February 2015 |
| 100 tablet in 1 bottle | 16571-835-01 | Rising Pharma Holdings | 6 June 2024 |
| 60 tablet in 1 bottle | 68071-3772-6 | NuCare Pharmaceuticals | 13 January 2025 |
| 60 tablet in 1 bottle | 68071-3997-6 | NuCare Pharmaceuticals,Inc | 5 May 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 68084-229-01 | American Health Packaging | 22 February 2008 |
| 9000 tablet in 1 bottle | 71610-124-09 | Aphena Pharma Solutions - Tennessee | 17 August 2018 |
| 100 tablet in 1 bottle | 42291-071-01 | AvKARE | 4 January 2022 |
| 100 tablet in 1 bottle | 51407-182-01 | Golden State Medical Supply | 7 December 2018 |
| 30 tablet in 1 bottle, plastic | 72789-129-30 | PD-Rx Pharmaceuticals | 8 October 2020 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-3544-0 | Remedyrepack | 30 September 2022 |
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 Azathioprine 50 mg tablet.
Other strengths and forms of Azathioprine
Clinical summary
Azathioprine is a purine antimetabolite indicated as an adjunct for the prevention of rejection in renal homotransplantation, among other approved uses. It is available as tablets and powder for injection for oral and intravenous use. MedsAcross supplies Azathioprine 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 AzathioprineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IMURAN prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
- Jayempi: European public assessment report (EPAR) · European Medicines Agency
Need Azathioprine 50 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.