FDA.reportPublic FDA data

BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT

RxCUI
2387331
RxNorm name
BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT
Display name
BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT
Full name
BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BREZTRIBUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LP715433dc-cb2b-43ea-b6df-c5b4177adc6c2026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 2387331

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
715433dc-cb2b-43ea-b6df-c5b4177adc6cBREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUATSY7These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 202020260427
715433dc-cb2b-43ea-b6df-c5b4177adc6cBREZTRI 160/9/4.8 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN7These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 202020260427
715433dc-cb2b-43ea-b6df-c5b4177adc6c120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]SBD7These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 202020260427