Medicine
Mycophenolic acid 360 mg delayed-release tablet
Mycophenolic acid 360 mg delayed-release tablet is a generic prescription medicine for oral use, 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Mycophenolic acid
- Brand
- Sold under the generic name
- Strength
- 360 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 120 tablets
- Manufacturer
- Archis Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
- 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
- 21 February 2022
- Identifiers
- RxCUI 485020, 485023DailyMed set ID 30cb1078-929b-4c0f-be1d-49ef352dfab9NDC 72819-156Application ANDA091248
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet, delayed release in 1 bottle | 72819-156-08 | Archis Pharma | 21 February 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Mycophenolic acid
Clinical summary
Mycophenolic acid is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older, among other approved uses. MedsAcross supplies Mycophenolic acid 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 Mycophenolic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mycophenolic Acid prescribing information (Archis Pharma) · U.S. National Library of Medicine, DailyMed
Need Mycophenolic acid 360 mg delayed-release 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.