FDA.reportPublic FDA data

Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT

RxCUI
2597673
RxNorm name
Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT
Display name
Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT
Full name
Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

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
BREYNABUDESONIDE AND FORMOTEROL FUMARATEMylan Pharmaceuticals Inc.dc529fc4-bddb-4673-8202-dc401f86166f2025-11-15Warnings, Adverse reactionsExact identifier
rxcui: 2597673

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
dc529fc4-bddb-4673-8202-dc401f86166fBreyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT [PSN] · 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Breyna] [SBD] · Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT [SY]35These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620251115