FDA.reportPublic FDA data

aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT

RxCUI
1303102
RxNorm name
aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
Display name
aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
Full name
aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tudorza PressairACLIDINIUM BROMIDECovis Pharma US, Inc6f92cceb-a63f-4470-99b6-56179d98f10f2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1303102

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
6f92cceb-a63f-4470-99b6-56179d98f10faclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT [PSN] · 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [SCD] · 60 ACTUAT aclidinium bromide 400 MCG/ACTUAT Dry Powder Inhaler [SY] · aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT [SY]42These highlights do not include all the information needed to use TUDORZA PRESSAIR safely and effectively. See full prescribing information for TUDORZA PRESSAIR. TUDORZA ® PRESSAIR ® (aclidinium bromide inhalation powder) FOR ORAL INHALATION ONLY Initial U.S. Approval: 201220220801