United States· US:0310-4616_2d00a029-b36a-4a4f-8583-1af78a184682
BREZTRI
A medicinal product containing budesonide, glycopyrrolate, and formoterol fumarate, 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, and formoterol fumarate
- 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
- June 3, 2026
Packs & prices · 3
- ndc110310461612120 AEROSOL, METERED in 1 INHALER (0310-4616-12)
- ndc11031046162828 AEROSOL, METERED in 1 INHALER (0310-4616-28)
- ndc11031046163928 AEROSOL, METERED in 1 INHALER (0310-4616-39)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/99ac4ed0-9a6f-4ef9-a178-3da49c26fe81 GET /v1/drugs/99ac4ed0-9a6f-4ef9-a178-3da49c26fe81?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)",
"productid": "0310-4616_2d00a029-b36a-4a4f-8583-1af78a184682",
"productndc": "0310-4616",
"dosage_form": "AEROSOL, METERED",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE",
"proprietary_name": "BREZTRI",
"active_ingred_unit": "ug/1; ug/1; ug/1",
"application_number": "NDA212122",
"marketing_category": "NDA",
"nonproprietary_name": "budesonide, glycopyrrolate, and formoterol fumarate",
"start_marketing_date": "20200723",
"active_numerator_strength": "160; 4.8; 9"
}See everything about budesonide, glycopyrrolate, and formoterol fumarate.
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.