FDA.reportPublic FDA data

NDC 50090-4248-00 - Spiriva HandiHaler

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-4248
Requested NDC
50090-4248-00
Package NDCs from labels
50090-4248-0, 50090-4248-00
Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spiriva HandiHaler - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4248-02023-02-07C16284748780-1f386c649-a726-0266-e053-dadaa90a7c1aThese 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: 2004
50090-4248-02023-01-30C16284748780-1f386c649-a726-0266-e053-dadaa90a7c1aThese 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: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4248-0Spiriva HandiHaler10 in 1 BLISTER PACKCAPSULE103
50090-4248-0Spiriva HandiHaler3 in 1 CARTONCAPSULE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4248SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_ba462261-734a-4e9f-a5c0-5c676bc56a2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4248-0EA - Each50090-4248df141813-e497-4cbf-a142-455dd99fa2c012022-04-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiotropium BromideTIOTROPIUM BROMIDELupin Pharmaceuticals, Inc.496b38ee-45b6-4bb2-a35e-9023c3b737192025-11-11Warnings, Adverse reactionsExact identifier
rxcui: 485032
unii: L64SXO195N
Spiriva HandiHalerTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.820839ef-e53d-47e8-a3b9-d911ff92e6a92025-11-10Warnings, Adverse reactionsExact identifier
application number: NDA021395
ndc (product): 0597-0075
rxcui: 580261
rxcui: 485032
spl id: 94768574-0d3e-46f0-9f75-ab3c9f52857d
spl set id: 820839ef-e53d-47e8-a3b9-d911ff92e6a9
unii: L64SXO195N
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsc6343458-617b-41ed-8e96-763e91dc8e902025-09-02Warnings, Adverse reactionsExact identifier
application number: NDA021395
rxcui: 580261
rxcui: 485032
unii: L64SXO195N
Stiolto RespimatTIOTROPIUM BROMIDE AND OLODATEROLBoehringer Ingelheim Pharmaceuticals, Inc.01e15aee-40e0-23f3-537f-c96dd63e2cb12025-06-30Warnings, Adverse reactionsExact identifier
unii: L64SXO195N
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsba462261-734a-4e9f-a5c0-5c676bc56a2e2023-02-06Warnings, Adverse reactionsExact identifier
application number: NDA021395
ndc (package): 50090-4248-0
ndc (product): 50090-4248
ndc11 (package): 50090424800
rxcui: 580261
rxcui: 485032
spl id: fa0b0258-3ff1-4481-a289-2599b2e3fd76
spl set id: ba462261-734a-4e9f-a5c0-5c676bc56a2e
unii: L64SXO195N

Reported adverse events (FAERS/openFDA)#

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