Medicine
Mesalamine 500 mg extended-release capsule
Mesalamine 500 mg extended-release capsule is a generic prescription medicine for oral use, made by 2 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 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Mesalamine
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 120 capsules
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaSandoz
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EC02 Mesalamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 May 2022
- Identifiers
- RxCUI 314092, 476362DailyMed set ID 47b5d1ee-b439-4ccb-9b01-c0875ccd748a, c2f84490-70b8-4998-907d-a77e9f791de1NDC 0781-2793, 63304-089Application ANDA219997, ANDA214585
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 |
|---|---|---|---|
| 120 capsule, extended release in 1 bottle | 63304-089-13 | Sun Pharmaceutical IndustriesIndia | 13 May 2022 |
| 120 capsule, extended release in 1 bottle | 0781-2793-72 | Sandoz | 15 July 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 December 1987 | Drugs@FDA |
| 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 Mesalamine
Clinical summary
Mesalamine is an aminosalicylate indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. It is available as delayed-release tablets, extended-release capsules and suppositories for oral and rectal use. MedsAcross supplies Mesalamine 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 MesalamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rowasa prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Mesalamine 500 mg extended-release capsule 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.