FDA.reportPublic FDA data

aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations

RxCUI
2205094
RxNorm name
aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations
Display name
aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations
Full name
aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

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UNII Substances#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAKLIR PRESSAIRACLIDINIUM BROMIDE AND FORMOTEROL FUMARATECovis Pharma US, Inc2eba3089-28b4-4190-9fba-2511246cfd162022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 2205094

Reported adverse events (FAERS/openFDA)#

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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
2eba3089-28b4-4190-9fba-2511246cfd16aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations [PSN] · 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [SCD]21These highlights do not include all the information needed to use DUAKLIR PRESSAIR safely and effectively. See full prescribing information for DUAKLIR PRESSAIR. DUAKLIR ® PRESSAIR ® (aclidinium bromide and formoterol fumarate) inhalation powder, for oral inhalation Initial U.S. Approval: 201920220801