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#

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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 · 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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fafa4cf1-99c2-43d5-73ad-51f256de3be0budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN31These 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
fafa4cf1-99c2-43d5-73ad-51f256de3be0budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY31These 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
fafa4cf1-99c2-43d5-73ad-51f256de3be0budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY31These 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
fafa4cf1-99c2-43d5-73ad-51f256de3be060 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD31These 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 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8These 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
52f45e18-463e-4ce3-8ccd-c0260473e6b5budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY8These 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
52f45e18-463e-4ce3-8ccd-c0260473e6b5budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN8These 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
52f45e18-463e-4ce3-8ccd-c0260473e6b560 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD8These 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 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY1These 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
a645756c-c692-4bc6-a858-7e7e249561bdbudesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSY1These 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
a645756c-c692-4bc6-a858-7e7e249561bd60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD1These 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
a645756c-c692-4bc6-a858-7e7e249561bdbudesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN1These 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