FDA.reportPublic FDA data

Spiriva

Product NDC
50090-4248
11-digit product format
500904248
Labeler code
50090
Product ID
50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76
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
Substance
TIOTROPIUM BROMIDE MONOHYDRATE
Active strength
18 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 50090-4248

Additional Listing Data#

Finished product
Yes
Brand name base
Spiriva
Brand name suffix
HandiHaler
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOTROPIUM BROMIDE MONOHYDRATE18 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L64SXO195NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485032Internal RxNorm lookup
580261Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba462261-734a-4e9f-a5c0-5c676bc56a2eAvailable on FDA.report

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
50090-4248-02023-02-07C16284748780-1f386c649-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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSNba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderPSNba462261-734a-4e9f-a5c0-5c676bc56a2e3
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBDba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 0.018 MG Inhalation PowderSCDba462261-734a-4e9f-a5c0-5c676bc56a2e3
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
580261Spiriva HandiHaler 18 MCG Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4248-0500904248003 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2019-04-020000-00-00NoNoCurrent