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

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 Identifiers#

Field, Values table
FieldValues
UniiL64SXO195N
Rxcui485032, 580261

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