Medicine
Indomethacin 50 mg suppository
Indomethacin 50 mg suppository is a generic prescription medicine for rectal use, made by 5 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated between 2°C to 8°C (36°F to 46°F).
Key facts
- Active ingredient (INN)
- Indomethacin
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Suppository
- Route
- Rectal
- Packs
- 5 blister pack, 30 suppositories, 30 blister pack and 4 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaAmneal Pharmaceuticals NYHikma PharmaceuticalsNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2°C to 8°C (36°F to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- 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
- 3 August 2023
- Identifiers
- RxCUI 197819DailyMed set ID 595e2f3e-c6d4-4a17-bc06-46512b4275b5, 8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a, c81343f2-5ef5-4635-9b94-5ac8d72aa61e +4NDC 70710-1852, 69238-2086, 31722-051 +4Application ANDA216184, ANDA215399, ANDA216905 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 blister pack in 1 carton / 6 suppository in 1 blister pack | 70710-1852-7 | Zydus LifesciencesIndia | 3 August 2023 |
| 5 blister pack in 1 carton / 6 suppository in 1 blister pack | 70710-1958-7 | Zydus LifesciencesIndia | 15 April 2024 |
| 5 blister pack in 1 carton / 6 suppository in 1 blister pack | 70771-1766-7 | Zydus LifesciencesIndia | 3 August 2023 |
| 30 suppository in 1 carton | 31722-051-31 | Camber PharmaceuticalsIndia | 3 July 2025 |
| 30 suppository in 1 box | 69238-2086-3 | Amneal Pharmaceuticals NY | 26 February 2025 |
| 30 suppository in 1 box | 0054-1950-30 | Hikma Pharmaceuticals | 20 November 2024 |
| 30 blister pack in 1 carton / 6 suppository in 1 blister pack | 72603-281-30 | NorthStar RxLLC | 20 December 2025 |
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
Alternatives
Other makers and brands of Indomethacin 50 mg suppository.
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 50 mg suppository 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.