FDA.reportPublic FDA data

Spiriva HandiHaler 18 MCG Inhalation Powder

RxCUI
580261
RxNorm name
Spiriva HandiHaler 18 MCG Inhalation Powder
Display name
Spiriva HandiHaler 18 MCG Inhalation Powder
Full name
Spiriva HandiHaler 18 MCG Inhalation Powder
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spiriva HandiHalerTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.820839ef-e53d-47e8-a3b9-d911ff92e6a92025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 580261
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsc6343458-617b-41ed-8e96-763e91dc8e902025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 580261
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsba462261-734a-4e9f-a5c0-5c676bc56a2e2023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 580261

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
820839ef-e53d-47e8-a3b9-d911ff92e6a9SPIRIVA HandiHaler 18 MCG Inhalation Powder [PSN] · tiotropium 0.018 MG Inhalation Powder [Spiriva] [SBD] · Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder [SY] · Spiriva HandiHaler 18 MCG Inhalation Powder [SY]428These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 200420251110
ba462261-734a-4e9f-a5c0-5c676bc56a2eSPIRIVA HandiHaler 18 MCG Inhalation Powder [PSN] · tiotropium 0.018 MG Inhalation Powder [Spiriva] [SBD] · Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder [SY] · Spiriva HandiHaler 18 MCG Inhalation Powder [SY]43These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 200420230206
25a4cb05-64a8-44b6-88c8-4292a5292e92SPIRIVA HandiHaler 18 MCG Inhalation Powder [PSN] · tiotropium 0.018 MG Inhalation Powder [Spiriva] [SBD] · Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder [SY] · Spiriva HandiHaler 18 MCG Inhalation Powder [SY]43These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 200420200515
c6343458-617b-41ed-8e96-763e91dc8e90SPIRIVA HandiHaler 18 MCG Inhalation Powder [PSN] · tiotropium 0.018 MG Inhalation Powder [Spiriva] [SBD] · Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder [SY] · Spiriva HandiHaler 18 MCG Inhalation Powder [SY]41These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 200420250902