Medicine
Mesalamine 1.2 g delayed-release tablet
Mesalamine 1.2 g delayed-release tablet is a generic prescription medicine for oral use, made by 13 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Mesalamine
- Brand
- Sold under the generic name
- Strength
- 1.2 g
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 120 tablets, 34 tablets, 500 tablets and 16 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackChartwell RXActavis PharmaAmerican Health PackagingGolden State Medical SupplyLannettMajor Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
- 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
- 5 June 2017
- Identifiers
- RxCUI 686429DailyMed set ID 29dbe417-15a9-4c4d-846b-81cabda7ac70, 04ce2182-2e8c-4598-a269-550cfaddde6c, fd8b02de-7dfa-444d-a1f8-1436b578e0cb +12NDC 0527-3012, 31722-043, 63304-175 +12Application ANDA217337, ANDA216334, ANDA211858 +3
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 tablet, delayed release in 1 bottle | 68382-711-19 | Zydus LifesciencesIndia | 19 June 2017 |
| 34 tablet, delayed release in 1 bottle | 68382-711-64 | Zydus LifesciencesIndia | 19 June 2017 |
| 120 tablet, delayed release in 1 bottle | 70771-1071-1 | Zydus LifesciencesIndia | 19 June 2017 |
| 34 tablet, delayed release in 1 bottle | 70771-1071-2 | Zydus LifesciencesIndia | 19 June 2017 |
| 500 tablet, delayed release in 1 bottle | 31722-043-05 | Camber PharmaceuticalsIndia | 5 February 2024 |
| 120 tablet, delayed release in 1 bottle | 31722-043-12 | Camber PharmaceuticalsIndia | 5 February 2024 |
| 120 tablet, delayed release in 1 bottle | 63304-175-13 | Sun Pharmaceutical IndustriesIndia | 1 February 2019 |
| 120 tablet, delayed release in 1 bottle | 0591-2245-22 | Actavis Pharma | 26 March 2018 |
| 120 tablet, delayed release in 1 bottle | 62135-714-12 | Chartwell RX | 21 July 2023 |
| 60 tablet, delayed release in 1 bottle | 62135-714-60 | Chartwell RX | 21 July 2023 |
| 120 tablet, delayed release in 1 bottle | 0527-3012-48 | Lannett | 3 June 2023 |
| 120 tablet, delayed release in 1 bottle | 84612-175-13 | Nuvaila | 1 July 2026 |
| 120 tablet, delayed release in 1 bottle | 54092-100-01 | Takeda Pharmaceuticals | 29 August 2017 |
| 120 tablet, delayed release in 1 bottle | 72162-2213-2 | Bryant Ranch Prepack | 29 May 2024 |
| 120 tablet, delayed release in 1 bottle | 72162-2231-2 | Bryant Ranch Prepack | 14 August 2024 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, delayed release in 1 blister pack | 60687-397-25 | American Health Packaging | 11 October 2018 |
| 120 tablet, delayed release in 1 bottle | 51407-900-12 | Golden State Medical Supply | 25 April 2024 |
| 30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-6832-04 | Major Pharmaceuticals | 19 June 2017 |
| 120 tablet, delayed release in 1 bottle | 72603-304-01 | NorthStar RxLLC | 1 December 2024 |
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
Alternatives
Other makers and brands of Mesalamine 1.2 g delayed-release tablet.
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 1.2 g delayed-release tablet for your hospital or patient?
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