Medicine
Indomethacin 1 mg/mL powder for injection
Indomethacin 1 mg/mL powder for injection is a generic prescription medicine for intravenous use, 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 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Indomethacin
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturer
- Fresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Store container in carton until contents have been used. www.fresenius-kabi.com/us 451150C Fresenius Kabi Logo
- 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
- 19 March 2010
- Identifiers
- RxCUI 346508DailyMed set ID ec482425-358c-4500-8f5d-79c1379c1fa8, dd5caa3f-3c09-4034-bf43-2df80c61c07b, 30e38747-c553-4e2d-bc23-634e1dd90b8dNDC 63323-659Application NDA022536
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 1 mL in 1 vial | 63323-659-03 | Fresenius Kabi | 19 March 2010 |
| 1 vial in 1 carton / 1 mL in 1 vial | 63323-659-09 | Fresenius Kabi | 19 March 2010 |
| 1 vial in 1 carton / 1 mL in 1 vial | 63323-659-94 | Fresenius Kabi | 19 March 2010 |
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 1 mg/mL powder for injection 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.