FDA.reportPublic FDA data

30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler

RxCUI
2205103
RxNorm name
30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler
Display name
30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler
Full name
30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

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 · 1 matching rows.

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: 2205103

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, 30 Actuations [PSN] · 30 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