Medicine
Mycophenolate 500 mg tablet
Mycophenolate 500 mg tablet is a generic prescription medicine for oral use, made by 20 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).
Key facts
- Active ingredient (INN)
- Mycophenolate
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 100 tablets, 10 blister pack and 36 more
- Manufacturers
- Ascend LaboratoriesIndiaConcord BiotechIndiaStrides PharmaIndiaAccord HealthcareIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaCamber PharmaceuticalsIndiaProficient RxSandozAdvagen Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AA06 Mycophenolate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 July 2008
- Identifiers
- RxCUI 199058, 200060DailyMed set ID 741e079a-646b-47ec-84ac-8e12574c2aaf, 8015f042-54fb-4a7a-a10b-6219e1a450c8, afb59492-2bb1-4cf1-af4b-a5020b56c124 +19NDC 16729-019, 60687-438, 70518-2767 +19Application ANDA065416, ANDA090456, ANDA208119 +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 |
|---|---|---|---|
| 500 tablet, film coated in 1 bottle, plastic | 42543-989-07 | Strides PharmaIndia | 28 February 2025 |
| 100 tablet, film coated in 1 bottle, plastic | 64380-725-06 | Strides PharmaIndia | 6 November 2010 |
| 500 tablet, film coated in 1 bottle, plastic | 64380-725-07 | Strides PharmaIndia | 6 November 2010 |
| 100 tablet in 1 bottle | 16729-019-01 | Accord HealthcareIndia | 4 May 2009 |
| 500 tablet in 1 bottle | 16729-019-16 | Accord HealthcareIndia | 4 May 2009 |
| 100 tablet, film coated in 1 bottle | 67877-225-01 | Ascend LaboratoriesIndia | 28 November 2011 |
| 500 tablet, film coated in 1 bottle | 67877-225-05 | Ascend LaboratoriesIndia | 28 November 2011 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-225-38 | Ascend LaboratoriesIndia | 28 November 2011 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-225-84 | Ascend LaboratoriesIndia | 28 November 2011 |
| 100 tablet, film coated in 1 bottle | 59651-638-01 | Aurobindo PharmaIndia | 20 February 2024 |
| 500 tablet, film coated in 1 bottle | 59651-638-05 | Aurobindo PharmaIndia | 20 February 2024 |
| 100 tablet, film coated in 1 bottle, plastic | 23155-836-01 | Avet PharmaceuticalsIndia | 15 October 2022 |
| 500 tablet, film coated in 1 bottle, plastic | 23155-836-05 | Avet PharmaceuticalsIndia | 15 October 2022 |
| 100 tablet, film coated in 1 bottle | 31722-879-01 | Camber PharmaceuticalsIndia | 22 October 2024 |
| 500 tablet, film coated in 1 bottle | 31722-879-05 | Camber PharmaceuticalsIndia | 22 October 2024 |
| 30 tablet in 1 bottle | 68254-5003-1 | Concord BiotechIndia | 21 December 2020 |
| 100 tablet in 1 bottle | 68254-5003-2 | Concord BiotechIndia | 21 December 2020 |
| 500 tablet in 1 bottle | 68254-5003-3 | Concord BiotechIndia | 21 December 2020 |
| 100 tablet in 1 bottle | 72888-185-01 | Advagen Pharma | 1 August 2023 |
| 500 tablet in 1 bottle | 72888-185-05 | Advagen Pharma | 1 August 2023 |
| 100 tablet in 1 bottle | 0054-0166-25 | Hikma Pharmaceuticals | 29 July 2008 |
| 500 tablet in 1 bottle | 0054-0166-29 | Hikma Pharmaceuticals | 29 July 2008 |
| 100 tablet, film coated in 1 bottle | 0781-5175-01 | Sandoz | 15 October 2008 |
| 500 tablet, film coated in 1 bottle | 0781-5175-05 | Sandoz | 15 October 2008 |
| 1000 tablet, film coated in 1 bottle | 0781-5175-10 | Sandoz | 15 October 2008 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-2767-1 | Remedyrepack | 16 December 2021 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-4377-0 | Remedyrepack | 30 June 2025 |
| 180 tablet, film coated in 1 bottle | 50090-4275-0 | A-S Medication Solutions | 19 April 2019 |
| 100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 60687-438-01 | American Health Packaging | 14 June 2019 |
| 100 tablet, film coated in 1 bottle | 73190-010-01 | AvKARE | 25 April 2025 |
| 500 tablet, film coated in 1 bottle | 73190-010-50 | AvKARE | 25 April 2025 |
| 50 blister pack in 1 box / 1 tablet, film coated in 1 blister pack | 50268-558-15 | AvPAK | 15 May 2023 |
| 120 tablet in 1 bottle | 63629-9582-1 | Bryant Ranch Prepack | 15 November 2022 |
| 10 blister pack in 1 bag / 1 tablet, film coated in 1 blister pack | 55154-3571-0 | Cardinal Health | 6 November 2010 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-7078-61 | Major Pharmaceuticals | 6 November 2010 |
| 60 tablet, film coated in 1 bottle, plastic | 68071-3767-6 | NuCare Pharmaceuticals | 13 January 2025 |
| 30 tablet, film coated in 1 bottle, plastic | 82804-033-30 | Proficient Rx | 25 October 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 82804-033-60 | Proficient Rx | 25 October 2023 |
| 90 tablet, film coated in 1 bottle, plastic | 82804-033-90 | Proficient Rx | 25 October 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 Mycophenolate 500 mg tablet.
Other strengths and forms of Mycophenolate
Clinical summary
Mycophenolate is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. MedsAcross supplies Mycophenolate 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 MycophenolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CellCept prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- CellCept: European public assessment report (EPAR) · European Medicines Agency
- Myclausen: European public assessment report (EPAR) · European Medicines Agency
Need Mycophenolate 500 mg tablet for your hospital or patient?
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