FDA.reportPublic FDA data

Spiriva

Product NDC
50090-4414
11-digit product format
500904414
Labeler code
50090
Product ID
50090-4414_22fe8b5c-76a9-407d-9fec-9761e54555eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIOTROPIUM BROMIDE
Dosage form
CAPSULE
Route
ORAL; RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021395
Marketing category
NDA
Marketing start
2005-10-11
Marketing end
0000-00-00
Substance
TIOTROPIUM BROMIDE MONOHYDRATE
Active strength
18 ug/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4414IInactivated by FDA2026-08-03
excluded packagepackage50090-441450090-4414-0IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021395-001SPIRIVATIOTROPIUM BROMIDEEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021395-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021395-00180220822026-01-19U-1186Drug product2011-10-24
N021395-0018022082*PED2026-07-19Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021395-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021395-00180220822026-01-19U-1186Drug product2011-10-24a50c72e98297…
2026-08-01 22:54:322026-06N021395-0018022082*PED2026-07-19Pediatric extensiona50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
application applno (NDA): 021395
application number: NDA021395
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsc6343458-617b-41ed-8e96-763e91dc8e902025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021395
application number: NDA021395
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsba462261-734a-4e9f-a5c0-5c676bc56a2e2023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021395
application number: NDA021395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48c4d28d-b099-457f-b725-6536a67545d9Product name120240723
e5bad22a-8b64-476c-b12b-bcb1efd8adfcProduct name320210727
b2bc1652-3709-4d21-bd76-c433f7f7103eProduct name120150610

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4414-02023-01-30C16284748780-1f386c649-ea5e-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
50090-4414-0Spiriva9 in 1 CARTONCAPSULE93
50090-4414-0Spiriva10 in 1 BLISTER PACKCAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4414-0EA - Each50090-4414bdef023d-1f60-4df5-b4d1-b0a60a4d62a412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4414SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200516_25a4cb05-64a8-44b6-88c8-4292a5292e92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSN25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 18 MCG Inhalation PowderPSN25a4cb05-64a8-44b6-88c8-4292a5292e923
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBD25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 0.018 MG Inhalation PowderSCD25a4cb05-64a8-44b6-88c8-4292a5292e923
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
580261Spiriva HandiHaler 18 MCG Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 18 MCG Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4414-0500904414009 BLISTER PACK in 1 CARTON (50090-4414-0) > 10 CAPSULE in 1 BLISTER PACK9 blister pack2019-07-160000-00-00NoNoCurrent