Medicine
Mycophenolate 500 mg/20 mL powder for injection
Mycophenolate 500 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 6 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 powder and reconstituted infusion solution at 25°C (77°F), excursions…
Key facts
- Active ingredient (INN)
- Mycophenolate
- Brand
- Sold under the generic name
- Strength
- 500 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 4 vials and 3 more
- Manufacturers
- Armas PharmaceuticalsBPI LabsMeitheal PharmaceuticalsMylan InstitutionalOnesource Specialty PharmaPar Health
- Origin register
- US FDA, United States
- Storage
- Store powder and reconstituted infusion solution 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
- L04AA06 Mycophenolate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 October 2016
- Identifiers
- RxCUI 311881DailyMed set ID ffcc237c-f31b-77b8-e053-6294a90a603e, 9650af9b-d36f-4a2f-9647-d0f798933402, 35ba0428-e267-49a5-99a9-c58853f7989d +3NDC 72485-415, 71288-803, 42023-172 +3Application ANDA216390, ANDA212130, ANDA203575 +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 |
|---|---|---|---|
| 4 vial in 1 carton / 20 mL in 1 vial | 72485-415-04 | Armas Pharmaceuticals | 6 July 2023 |
| 4 vial in 1 carton / 20 mL in 1 vial | 54288-141-04 | BPI Labs | 8 March 2023 |
| 4 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 71288-803-21 | Meitheal Pharmaceuticals | 15 January 2021 |
| 4 vial in 1 carton / 20 mL in 1 vial | 67457-386-81 | Mylan Institutional | 26 January 2021 |
| 4 vial in 1 carton / 20 mL in 1 vial | 83270-000-04 | Onesource Specialty Pharma | 30 April 2023 |
| 4 vial in 1 carton / 20 mL in 1 vial | 42023-172-04 | Par Health | 28 October 2016 |
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/20 mL powder for injection.
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/20 mL powder for injection 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.