FDA.reportPublic FDA data

Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT

RxCUI
1303107
RxNorm name
Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
Display name
Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
Full name
Tudorza 400 MCG/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#

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
Tudorza PressairACLIDINIUM BROMIDECovis Pharma US, Inc6f92cceb-a63f-4470-99b6-56179d98f10f2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1303107

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
6f92cceb-a63f-4470-99b6-56179d98f10fTudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT [PSN] · 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [Tudorza] [SBD] · 60 ACTUAT Tudorza 0.4 MG/ACTUAT Dry Powder Inhaler [SY] · Tudorza 400 MCG/ACTUAT (aclidinium bromide 375 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 60 ACTUAT [SY] · Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT [SY]52These 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