Medicine
Mesalamine 0.375 g extended-release capsule
Mesalamine 0.375 g extended-release capsule is a generic prescription medicine for oral use, made by 12 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), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Mesalamine
- Brand
- Sold under the generic name
- Strength
- 0.375 g
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 120 capsules, 1000 capsules, 500 capsules and 14 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAscend LaboratoriesIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaAmerican Health PackagingAvPAKGolden State Medical SupplyIngenus PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- 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
- 26 November 2019
- Identifiers
- RxCUI 825130DailyMed set ID 8d27a608-3ba1-4799-be38-c00fb08ce3ce, 4c4ffb68-3ca4-35cd-e063-6294a90ab929, 1e6978d0-01db-477d-a90f-27561777480f +10NDC 0093-9224, 51407-976, 0832-6056 +11Application NDA022301, ANDA217533, ANDA219864 +6
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 | 46708-724-35 | Alembic PharmaceuticalsIndia | 3 November 2022 |
| 1000 capsule, extended release in 1 bottle | 46708-724-91 | Alembic PharmaceuticalsIndia | 3 November 2022 |
| 120 capsule, extended release in 1 bottle | 62332-724-35 | Alembic PharmaceuticalsIndia | 3 November 2022 |
| 1000 capsule, extended release in 1 bottle | 62332-724-91 | Alembic PharmaceuticalsIndia | 3 November 2022 |
| 120 capsule, extended release in 1 bottle | 68382-452-19 | Zydus LifesciencesIndia | 13 August 2021 |
| 120 capsule, extended release in 1 bottle | 70771-1625-7 | Zydus LifesciencesIndia | 13 August 2021 |
| 500 capsule, extended release in 1 bottle | 67877-717-05 | Ascend LaboratoriesIndia | 16 July 2021 |
| 120 capsule, extended release in 1 bottle | 67877-717-12 | Ascend LaboratoriesIndia | 16 July 2021 |
| 120 capsule, extended release in 1 bottle | 59651-397-08 | Aurobindo PharmaIndia | 31 March 2023 |
| 120 capsule, extended release in 1 bottle | 31722-489-12 | Camber PharmaceuticalsIndia | 13 August 2025 |
| 120 capsule, extended release in 1 bottle, plastic | 50742-371-12 | Ingenus Pharmaceuticals | 23 September 2024 |
| 120 capsule, extended release in 1 bottle, plastic | 0378-1375-78 | Mylan Pharmaceuticals | 26 November 2019 |
| 120 capsule, extended release in 1 bottle | 0093-9224-89 | Teva Pharmaceuticals | 5 January 2021 |
| 120 capsule, extended release in 1 bottle | 0832-6056-12 | Upsher-Smith Laboratories | 25 July 2023 |
| 20 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack | 60687-650-32 | American Health Packaging | 6 September 2022 |
| 50 blister pack in 1 box / 1 capsule, extended release in 1 blister pack | 50268-577-15 | AvPAK | 16 January 2023 |
| 120 capsule, extended release in 1 bottle | 51407-976-12 | Golden State Medical Supply | 9 February 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 0.375 g 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.