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Medicine

Indocin 50 mg suppository

Indomethacin · Rectal · Zyla Life Sciences
Available on requestPrescription onlyUS FDA Cold chain

Indocin 50 mg suppository is a prescription medicine containing Indomethacin for rectal 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

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°- 8°C (36°- 46°F).

Key facts

Active ingredient (INN)
Indomethacin
Brand
Indocin
Strength
50 mg
Dosage form
Suppository
Route
Rectal
Packs
30 suppositories
Marketing authorisation holder
Zyla Life Sciences
Manufacturer
Zyla Life Sciences
Origin register
US FDA, United States
Storage
Store refrigerated between 2°- 8°C (36°- 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
31 August 1992
Identifiers
RxCUI 197819, 206969DailyMed set ID 3b36645c-de5e-4263-ae06-2f6ff6a9add2NDC 69344-102Application ANDA073314

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

PackCodeLabelerMarketed since
30 suppository in 1 box69344-102-33Zyla Life Sciences31 August 1992

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 10 June 1965Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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.

Compare 1

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 Indomethacin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Indocin 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.