FDA.reportPublic FDA data

120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler

RxCUI
1246311
RxNorm name
120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler
Display name
120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler
Full name
120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

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
DuleraMOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATEOrganon LLC8f399784-f257-4f31-b3dc-368bf2a1864d2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 1246311

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
8f399784-f257-4f31-b3dc-368bf2a1864dmometasone furoate/formoterol fumarate 200/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations [PSN] · 120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [SCD] · formoterol fumarate 0.005 MG / mometasone furoate 0.2 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY] · formoterol fumarate 5 MCG / mometasone furoate 200 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT [SY]47These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 201020260130