United States· US:68462-325_e729f88c-b2c8-4462-98be-7184de95b01d

indomethacin

A medicinal product containing indomethacin, registered in United States by Glenmark Pharmaceuticals Inc., USA.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedindomethacinATC—REGISTER NO.US:68462-325_e729f88c…PACKS LISTED10CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
INDOMETHACIN
Manufacturer
Glenmark Pharmaceuticals Inc., USA
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 · 10

  • ndc11
    68462-325-05
  • ndc11
    68462-325-10
  • ndc11
    68462-325-60
  • ndc11
    68462-325-90
  • ndc11
    6846232501
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01)
  • ndc11
    6846232505
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05)
  • ndc11
    6846232510
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10)
  • ndc11
    6846232560
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60)
  • ndc11
    6846232590
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)
  • ndc11
    68462-325-01

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.

All indomethacin products

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/89aea631-5414-4c59-9b0b-c4cb0294f6d9
GET /v1/drugs/89aea631-5414-4c59-9b0b-c4cb0294f6d9?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": "75",
  "substance": "INDOMETHACIN",
  "productndc": "68462-325",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA203501",
  "marketing_category": "ANDA"
}

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.