# BREZTRI

NDC: 0310-6616
Generic name: budesonide, glycopyrrolate, and formoterol fumarate
Labeler / Manufacturer: AstraZeneca Pharmaceuticals LP
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: AEROSOL, METERED
Routes: RESPIRATORY (INHALATION)
Marketing started: 20260427

FDA application: NDA212122

## Active ingredients

- BUDESONIDE: 160 ug/1
- FORMOTEROL: 4.8 ug/1
- GLYCOPYRROLATE: 7.2 ug/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0310-6616"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0310-6616
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=715433dc-cb2b-43ea-b6df-c5b4177adc6c
