Medicine
Mycophenolate 200 mg/mL powder for oral suspension
Mycophenolate 200 mg/mL powder for oral suspension is a generic prescription medicine for oral use, made by 11 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable. Do not…
Key facts
- Active ingredient (INN)
- Mycophenolate
- Brand
- Sold under the generic name
- Strength
- 200 mg/mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle and 8 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaStrides PharmaIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals NYLannettNorthStar RxQuagen PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable. Do not freeze. Store dry powder at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store constituted suspension at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) for up to 60 days.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 17 November 2014
- Identifiers
- RxCUI 311880DailyMed set ID c1c4cb31-00a7-417e-9775-24e849d62791, 838449b3-4397-4e35-b9b9-683f5a48bff2, 127eabe2-8386-452a-ad6b-d879e1f2c099 +7NDC 64380-899, 70752-294, 72603-751 +8Application ANDA212634, ANDA214525, ANDA218227 +4
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 |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 67877-230-22 | Ascend LaboratoriesIndia | 17 November 2014 |
| 1 bottle in 1 carton / 225 mL in 1 bottle | 59651-646-26 | Aurobindo PharmaIndia | 26 September 2024 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 23155-848-51 | Avet PharmaceuticalsIndia | 5 September 2023 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 64380-899-00 | Strides PharmaIndia | 1 September 2026 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 69238-1595-2 | Amneal Pharmaceuticals | 5 November 2021 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 60219-1595-2 | Amneal Pharmaceuticals NY | 21 March 2024 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 0527-5160-82 | Lannett | 29 July 2021 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 70752-294-60 | Quagen Pharmaceuticals | 6 August 2026 |
| 1 bottle, plastic in 1 carton / 225 mL in 1 bottle, plastic | 16571-282-17 | Rising Pharma Holdings | 15 October 2026 |
| 1 bottle, plastic in 1 carton / 250 mL in 1 bottle, plastic | 66689-307-08 | VistaPharm | 15 February 2019 |
| 1 bottle in 1 carton / 225 mL in 1 bottle | 72603-751-01 | NorthStar Rx | 1 March 2026 |
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 200 mg/mL powder for oral suspension.
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 200 mg/mL powder for oral suspension 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.