United States· US:66993-189_78029af6-3c01-4be0-8439-ec3c22b4abb7
Umeclidinium Ellipta
A medicinal product containing umeclidinium bromide, registered in United States by Prasco Laboratories.
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
- UMECLIDINIUM BROMIDE
- Manufacturer
- Prasco Laboratories
- 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
- ndc1166993189971 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER
- ndc1166993-189-97
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.
- United KingdomIncruse Ellipta 55micrograms/dose dry powder inhalerPharmaram Ltd
- CzechiaINCRUSE ELLIPTAGlaxoSmithKline Trading Services Limited, Dublin
- BelgiumElebrato Ellipta 92 µg/dose - 22 µg/doseGlaxoSmithKline Trading Services
- SpainINCRUSE ELLIPTA 55 mcg POLVO PARA INHALACION UNIDOSISGlaxosmithkline Trading Services Limited
- FinlandIncruse ElliptaGlaxoSmithKline Trading Services Limited
- IrelandIncruse Ellipta 55 micrograms inhalation powder, pre-dispensedGlaxoSmithKline Trading Services Limited
- SwitzerlandIncruse Ellipta
- NetherlandsIncruse Ellipta 55 microgram inhalatiepoeder, voorverdeeldGlaxoSmithKline Trading Services Limited
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/28b2cc42-5b82-4823-82e1-e6fa83e14ad4 GET /v1/drugs/28b2cc42-5b82-4823-82e1-e6fa83e14ad4?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": "66993-189",
"dosage_form": "AEROSOL, POWDER",
"dea_schedule": null,
"strength_unit": "ug/1",
"application_number": "NDA205382",
"marketing_category": "NDA AUTHORIZED GENERIC"
}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.