FDA.reportPublic FDA data

Spiriva

Product NDC
0597-0075
11-digit product format
005970075
Labeler code
0597
Product ID
0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIOTROPIUM BROMIDE
Dosage form
CAPSULE
Route
ORAL; RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0075-41SpirivaHandiHaler10 in 1 BLISTER PACKCAPSULE1028
0597-0075-41SpirivaHandiHaler3 in 1 CARTONCAPSULE328
0597-0075-47SpirivaHandiHaler10 in 1 BLISTER PACKCAPSULE1028
0597-0075-47SpirivaHandiHaler9 in 1 CARTONCAPSULE928
0597-0075-75SpirivaHandiHaler1 in 1 CARTONCAPSULE128
0597-0075-75SpirivaHandiHaler5 in 1 BLISTER PACKCAPSULE528

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0075-41EA - Each0597-00753619c466-44bd-4ffe-9c7d-b4d0b8e7109312012-07-24
0597-0075-47EA - Each0597-0075572fc425-ddb1-4710-8180-c07a41cd2bc212012-07-24
0597-0075-75EA - Each0597-00751a8f804b-44c0-4591-bdc3-5d27c4976dce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIOTROPIUM BROMIDE MONOHYDRATEACTIVE INGREDIENTL64SXO195NSPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]18
TIOTROPIUMACTIVE MOIETY0EB439235FSPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]18
TIOTROPIUM BROMIDE MONOHYDRATEACTIVE INGREDIENTL64SXO195NSPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TIOTROPIUMACTIVE MOIETY0EB439235FSPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0075SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 6 package rows20250112_820839ef-e53d-47e8-a3b9-d911ff92e6a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSN820839ef-e53d-47e8-a3b9-d911ff92e6a928
485032tiotropium 18 MCG Inhalation PowderPSN820839ef-e53d-47e8-a3b9-d911ff92e6a928
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBD820839ef-e53d-47e8-a3b9-d911ff92e6a928
485032tiotropium 0.018 MG Inhalation PowderSCD820839ef-e53d-47e8-a3b9-d911ff92e6a928
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY820839ef-e53d-47e8-a3b9-d911ff92e6a928
580261Spiriva HandiHaler 18 MCG Inhalation PowderSY820839ef-e53d-47e8-a3b9-d911ff92e6a928
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY820839ef-e53d-47e8-a3b9-d911ff92e6a928
485032tiotropium 18 MCG Inhalation PowderSY820839ef-e53d-47e8-a3b9-d911ff92e6a928
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSN25a4cb05-64a8-44b6-88c8-4292a5292e923
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSNba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderPSNba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderPSN25a4cb05-64a8-44b6-88c8-4292a5292e923
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBD25a4cb05-64a8-44b6-88c8-4292a5292e923
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBDba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 0.018 MG Inhalation PowderSCD25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 0.018 MG Inhalation PowderSCDba462261-734a-4e9f-a5c0-5c676bc56a2e3
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
580261Spiriva HandiHaler 18 MCG Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
580261Spiriva HandiHaler 18 MCG Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderSYba462261-734a-4e9f-a5c0-5c676bc56a2e3
485032tiotropium 18 MCG Inhalation PowderSY25a4cb05-64a8-44b6-88c8-4292a5292e923
580261SPIRIVA HandiHaler 18 MCG Inhalation PowderPSNc6343458-617b-41ed-8e96-763e91dc8e901
485032tiotropium 18 MCG Inhalation PowderPSNc6343458-617b-41ed-8e96-763e91dc8e901
580261tiotropium 0.018 MG Inhalation Powder [Spiriva]SBDc6343458-617b-41ed-8e96-763e91dc8e901
485032tiotropium 0.018 MG Inhalation PowderSCDc6343458-617b-41ed-8e96-763e91dc8e901
580261Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYc6343458-617b-41ed-8e96-763e91dc8e901
580261Spiriva HandiHaler 18 MCG Inhalation PowderSYc6343458-617b-41ed-8e96-763e91dc8e901
485032tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation PowderSYc6343458-617b-41ed-8e96-763e91dc8e901
485032tiotropium 18 MCG Inhalation PowderSYc6343458-617b-41ed-8e96-763e91dc8e901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0075-41005970075413 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2005-10-110000-00-00NoNoCurrent
0597-0075-47005970075479 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK9 blister pack2005-10-110000-00-00NoNoCurrent
0597-0075-75005970075751 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACK1 blister pack2005-10-110000-00-00NoNoCurrent