Medicine
Indocin 25 mg/5 mL oral suspension
Indocin 25 mg/5 mL oral suspension is a prescription medicine containing Indomethacin for oral use, marketed by Zyla Life Sciences, 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
Do not freeze. Store below 30°C (86°F). Avoid temperatures above 50°C (122°F).
Key facts
- Active ingredient (INN)
- Indomethacin
- Brand
- Indocin
- Strength
- 25 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Zyla Life Sciences
- Manufacturer
- Zyla Life Sciences
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store below 30°C (86°F). Avoid temperatures above 50°C (122°F).
- 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
- 4 February 2019
- Identifiers
- RxCUI 206971, 310991DailyMed set ID 73878376-1d24-423b-9f37-3666e83c95daNDC 69344-101Application NDA018332
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 bottle, glass in 1 carton / 237 mL in 1 bottle, glass | 69344-101-01 | Zyla Life Sciences | 4 February 2019 |
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 25 mg/5 mL oral suspension.
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 Indocin 25 mg/5 mL oral suspension 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.