FDA.reportPublic FDA data

budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT

RxCUI
1246304
RxNorm name
budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
Display name
budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
Full name
budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
Term type
SY
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.

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UNII Substances#

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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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCd6cc66c9-6f97-4ea8-a787-30a048004c772026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1246304
BREYNABUDESONIDE AND FORMOTEROL FUMARATEMylan Pharmaceuticals Inc.dc529fc4-bddb-4673-8202-dc401f86166f2025-11-15Warnings, Adverse reactionsExact identifier
rxcui: 1246304
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions6b78d08a-e098-4188-8f7f-94fbd5f396ef2024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1246304
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions805764a1-65e1-4117-ac4a-7a54c3986cfe2024-06-28Warnings, Adverse reactionsExact identifier
rxcui: 1246304
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions5feb8f35-b237-477a-9836-2a6db2ed6fa72024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 1246304
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEA-S Medication Solutions0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a2023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 1246304
Budesonide and formoterol fumarate dihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATETeva Pharmaceuticals, Inc.dd352302-e2fe-4388-b4b0-00b34f6ebe482022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 1246304
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEAstraZeneca Pharmaceuticals LPfafa4cf1-99c2-43d5-73ad-51f256de3be02019-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1246304
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEAstraZeneca Pharmaceuticals LP1d266fe8-52e3-4f85-a037-c5c1afa15e602019-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1246304

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fafa4cf1-99c2-43d5-73ad-51f256de3be0budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 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
6b78d08a-e098-4188-8f7f-94fbd5f396efbudesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]415These 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: 200620241022
5feb8f35-b237-477a-9836-2a6db2ed6fa7budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]411These 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
805764a1-65e1-4117-ac4a-7a54c3986cfebudesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 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: 200620240628
1d266fe8-52e3-4f85-a037-c5c1afa15e60budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]46These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620190724
dc529fc4-bddb-4673-8202-dc401f86166fbudesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]45These 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
d6cc66c9-6f97-4ea8-a787-30a048004c77budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]43These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620260424
dd352302-e2fe-4388-b4b0-00b34f6ebe48budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]42These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE and FORMOTEROL FUMARATE DIHYDRATE inhalation aerosol, for oral inhalation use Initial U.S. Approval: 200620221101
0ce4cd21-ac96-4b39-9e1c-49f86c87fa1abudesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]41These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620230206
ca94e217-1828-4a7f-b7c3-3352f00a97d3budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [SCD] · budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]41These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 200620201221