Medicine
Indomethacin 75 mg extended-release capsule
Indomethacin 75 mg extended-release capsule 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 room temperature 20°C to 25°C (68°F to 77°F), with excursions…
Key facts
- Active ingredient (INN)
- Indomethacin
- Brand
- Sold under the generic name
- Strength
- 75 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 1000 capsules and 63 more
- Manufacturers
- Camber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaBryant Ranch PrepackAmneal PharmaceuticalsKVK-Tech13 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01EB03 Indomethacin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 March 2009
- Identifiers
- RxCUI 310992DailyMed set ID 5a65b650-ea9b-4d0d-b62f-5971df1e62b4, dc80228c-acae-44dc-9762-19bd1669bf45, 12f62bae-5fc0-4f8d-a8b4-446524bd53d1 +13NDC 68084-411, 10702-016, 31722-565 +13Application ANDA079175, ANDA201807, ANDA203501 +1
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
A sample of 40 packs from 13 labelers. The register lists 66 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, extended release in 1 bottle | 31722-565-01 | Camber PharmaceuticalsIndia | 24 July 2015 |
| 500 capsule, extended release in 1 bottle | 31722-565-05 | Camber PharmaceuticalsIndia | 24 July 2015 |
| 1000 capsule, extended release in 1 bottle | 31722-565-10 | Camber PharmaceuticalsIndia | 24 July 2015 |
| 30 capsule, extended release in 1 bottle | 31722-565-30 | Camber PharmaceuticalsIndia | 24 July 2015 |
| 60 capsule, extended release in 1 bottle | 31722-565-60 | Camber PharmaceuticalsIndia | 24 July 2015 |
| 100 capsule, extended release in 1 bottle | 68462-325-01 | Glenmark PharmaceuticalsIndia | 22 June 2017 |
| 500 capsule, extended release in 1 bottle | 68462-325-05 | Glenmark PharmaceuticalsIndia | 22 June 2017 |
| 1000 capsule, extended release in 1 bottle | 68462-325-10 | Glenmark PharmaceuticalsIndia | 22 June 2017 |
| 60 capsule, extended release in 1 bottle | 68462-325-60 | Glenmark PharmaceuticalsIndia | 22 June 2017 |
| 90 capsule, extended release in 1 bottle | 68462-325-90 | Glenmark PharmaceuticalsIndia | 22 June 2017 |
| 30 capsule, extended release in 1 bottle | 65162-506-03 | Amneal Pharmaceuticals | 6 December 2010 |
| 60 capsule, extended release in 1 bottle | 65162-506-06 | Amneal Pharmaceuticals | 6 December 2010 |
| 90 capsule, extended release in 1 bottle | 65162-506-09 | Amneal Pharmaceuticals | 6 December 2010 |
| 100 capsule, extended release in 1 bottle | 65162-506-10 | Amneal Pharmaceuticals | 6 December 2010 |
| 1000 capsule, extended release in 1 bottle | 65162-506-11 | Amneal Pharmaceuticals | 6 December 2010 |
| 500 capsule, extended release in 1 bottle | 65162-506-50 | Amneal Pharmaceuticals | 6 December 2010 |
| 100 capsule, extended release in 1 bottle | 10702-016-01 | KVK-Tech | 6 March 2009 |
| 30 capsule, extended release in 1 bottle | 10702-016-03 | KVK-Tech | 2 February 2011 |
| 60 capsule, extended release in 1 bottle | 10702-016-06 | KVK-Tech | 6 March 2009 |
| 90 capsule, extended release in 1 bottle | 10702-016-09 | KVK-Tech | 2 February 2011 |
| 1000 capsule, extended release in 1 bottle | 10702-016-10 | KVK-Tech | 6 March 2009 |
| 500 capsule, extended release in 1 bottle | 10702-016-50 | KVK-Tech | 6 March 2009 |
| 60 capsule, extended release in 1 bottle | 63629-1915-1 | Bryant Ranch Prepack | 14 January 2021 |
| 30 capsule, extended release in 1 bottle | 71335-0756-1 | Bryant Ranch Prepack | 24 July 2015 |
| 60 capsule, extended release in 1 bottle | 71335-0756-2 | Bryant Ranch Prepack | 24 July 2015 |
| 14 capsule, extended release in 1 bottle | 71335-0756-3 | Bryant Ranch Prepack | 24 July 2015 |
| 10 capsule, extended release in 1 bottle | 71335-0756-4 | Bryant Ranch Prepack | 24 July 2015 |
| 7 capsule, extended release in 1 bottle | 71335-0756-5 | Bryant Ranch Prepack | 24 July 2015 |
| 15 capsule, extended release in 1 bottle | 71335-0756-6 | Bryant Ranch Prepack | 24 July 2015 |
| 20 capsule, extended release in 1 bottle | 71335-0756-7 | Bryant Ranch Prepack | 24 July 2015 |
| 90 capsule, extended release in 1 bottle | 71335-0756-8 | Bryant Ranch Prepack | 24 July 2015 |
| 100 capsule, extended release in 1 bottle | 71335-0756-9 | Bryant Ranch Prepack | 24 July 2015 |
| 30 capsule, extended release in 1 bottle | 71335-9754-1 | Bryant Ranch Prepack | 21 September 2023 |
| 60 capsule, extended release in 1 bottle | 71335-9754-2 | Bryant Ranch Prepack | 9 April 2024 |
| 14 capsule, extended release in 1 bottle | 71335-9754-3 | Bryant Ranch Prepack | 1 August 2023 |
| 10 capsule, extended release in 1 bottle | 71335-9754-4 | Bryant Ranch Prepack | 9 April 2024 |
| 7 capsule, extended release in 1 bottle | 71335-9754-5 | Bryant Ranch Prepack | 9 April 2024 |
| 15 capsule, extended release in 1 bottle | 71335-9754-6 | Bryant Ranch Prepack | 9 April 2024 |
| 20 capsule, extended release in 1 bottle | 71335-9754-7 | Bryant Ranch Prepack | 9 April 2024 |
| 90 capsule, extended release in 1 bottle | 71335-9754-8 | Bryant Ranch Prepack | 9 April 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 10 June 1965 | 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 Indomethacin
Clinical summary
Indomethacin is a nonsteroidal anti-inflammatory drug. It is available as capsules, extended-release capsules and suppositories for oral, rectal and intravenous use. MedsAcross supplies Indomethacin 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 IndomethacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INDOMETHACIN prescribing information (Chartwell RX) · U.S. National Library of Medicine, DailyMed
Need Indomethacin 75 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.