United States· US:69344-101_58959f55-f324-4433-97fc-c3b1b7c199be
Indocin
A medicinal product containing indomethacin, registered in United States by Zyla Life Sciences US LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- INDOMETHACIN
- Manufacturer
- Zyla Life Sciences US LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1169344-101-01
- ndc1169344101011 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Indomethacin in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBerlind 75 Retard capsulesTillomed Laboratories Ltd
- NorwayIndocidHAC Pharma
- FinlandConfortidAlpharma ApS
- PolandElmetacinInPharm Sp. z o.o.
- SpainALIVIOSIN 100 mg SUPOSITORIOSEspecialidades Farmaceuticas Centrum S.A.
- CanadaAURO-INDOMETHACINAURO PHARMA INC
- BelgiumDolcidium 100 mgLaboratoires S.M.B.
- SwitzerlandElmetacin, LösungMedinova AG
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Indocid, Mobiflex
- Belgium · Indocollyre, Sportflex
- Bulgaria · Индометацин Дс, Индометацин Софарма
- Cyprus · Indorem, Indylon
- Czechia · Elmetacin, Indocollyre
- Germany · Indometacin Al
- Spain · Aliviosin, Artrinovo
- France · Chrono-Indocid, Indocid
- United Kingdom (Northern Ireland) · Berlind Retard, Indolar Sr
- Greece · Fortathrin, Reumadolor
- Croatia · Indometacin Belupo
- Hungary · Indocollyre
- Italy · Indocollirio, Indom
- Lithuania · Metindol
- Luxembourg · Indocollyre, Sportflex
- Latvia · Indometacin Sopharma, Metindol
- Netherlands · Indometacine Aurobindo, Indometacine Cf
- Poland · Elmetacin, Metindol Retard
- Portugal · Autritis, Elmetacin
- Romania · Indocollyre, Indometacin Arena
- Slovakia · Elmetacin, Indometacin Berlin-Chemie
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/6d0974a3-dc1e-4394-a061-02c5e33fa2c8 GET /v1/drugs/6d0974a3-dc1e-4394-a061-02c5e33fa2c8?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "25",
"substance": "INDOMETHACIN",
"productndc": "69344-101",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/5mL",
"application_number": "NDA018332",
"marketing_category": "NDA"
}See everything about indomethacin.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.