FDA.reportPublic FDA data

budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations

RxCUI
1246314
RxNorm name
budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations
Display name
budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations
Full name
budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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#

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCa645756c-c692-4bc6-a858-7e7e249561bd2026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 1246314
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions52f45e18-463e-4ce3-8ccd-c0260473e6b52024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 1246314
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEAstraZeneca Pharmaceuticals LPfafa4cf1-99c2-43d5-73ad-51f256de3be02019-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1246314

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fafa4cf1-99c2-43d5-73ad-51f256de3be0budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations [PSN] · 60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY] · budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY]431These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620190724
52f45e18-463e-4ce3-8ccd-c0260473e6b5budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations [PSN] · 60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY] · budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY]48These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620240415
a645756c-c692-4bc6-a858-7e7e249561bdbudesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations [PSN] · 60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY] · budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT [SY]41These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620260312