United States· US:0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415f

Incruse Ellipta

A medicinal product containing umeclidinium bromide, registered in United States by GlaxoSmithKline LLC.

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…normalisedIncruse ElliptaATC—REGISTER NO.US:0173-0873_4049ca45…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
UMECLIDINIUM BROMIDE
Manufacturer
GlaxoSmithKline 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 · 4

  • ndc11
    0173087306
    1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER
  • ndc11
    0173087310
    1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER
  • ndc11
    0173-0873-10
  • ndc11
    0173-0873-06

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Umeclidinium bromide in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All umeclidinium bromide products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Incruse Ellipta, Rolufta Ellipta
  • Liechtenstein · Incruse Ellipta, Rolufta Ellipta
  • Norway · Incruse Ellipta, Rolufta Ellipta

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/f7b2e269-5543-4b60-9770-7e5e6d345267
GET /v1/drugs/f7b2e269-5543-4b60-9770-7e5e6d345267?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": "62.5",
  "substance": "UMECLIDINIUM BROMIDE",
  "productndc": "0173-0873",
  "dosage_form": "AEROSOL, POWDER",
  "dea_schedule": null,
  "strength_unit": "ug/1",
  "application_number": "NDA205382",
  "marketing_category": "NDA"
}

See everything about umeclidinium bromide.

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.