FDA.reportPublic FDA data

budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler

RxCUI
2387326
RxNorm name
budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler
Display name
budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler
Full name
budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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: 2387326

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
715433dc-cb2b-43ea-b6df-c5b4177adc6cbudesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler [PSN] · 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler [SY]37These 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