United States· US:0310-4616_0437e8e6-972d-4b1b-885c-ed28c5c43214
BREZTRI
A medicinal product containing budesonide; glycopyrrolate; formoterol, registered in United States by AstraZeneca Pharmaceuticals LP.
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
- BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- 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 · 3
- ndc110310-4616-12
- ndc110310-4616-28
- ndc110310-4616-39
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Budesonide; glycopyrrolate; formoterol in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaTRIXEO AEROSPHEREAstraZeneca AB, Södertälje
- FinlandRiltrava AerosphereAstraZeneca AB
- IrelandRiltrava Aerosphere 5/7.2/160 micrograms pressurised inhalation, suspensionAstraZeneca AB
- SwedenRiltrava Aerosphere 5 mikrogram/7,2 mikrogram/160 mikrogram Inhalationsspray, suspensionAstraZeneca AB
- NorwayTrixeo AerosphereAstraZeneca AB (2)
- United KingdomTrixeo Aerosphere 5micrograms/dose / 7.2micrograms/dose / 160micrograms/dose pressurised inhalerAstraZeneca UK Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Riltrava Aerosphere, Trixeo Aerosphere
- Liechtenstein · Riltrava Aerosphere, Trixeo Aerosphere
- Norway · Riltrava Aerosphere, Trixeo Aerosphere
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/9ed68aed-b00a-4fba-8e25-f0834e17e814 GET /v1/drugs/9ed68aed-b00a-4fba-8e25-f0834e17e814?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": "RESPIRATORY (INHALATION)",
"source": "ndc",
"strength": "160; 9; 4.8",
"substance": "BUDESONIDE; GLYCOPYRROLATE; FORMOTEROL",
"productndc": "0310-4616",
"dosage_form": "AEROSOL, METERED",
"dea_schedule": null,
"strength_unit": "ug/1; ug/1; ug/1",
"application_number": "NDA212122",
"marketing_category": "NDA"
}See everything about budesonide; glycopyrrolate; formoterol.
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.