FDA.reportPublic FDA data

Spiriva Respimat

Product NDC
0597-0100
11-digit product format
005970100
Labeler code
0597
Product ID
0597-0100_3a3c2a57-54e9-421c-9d5b-390076a40cc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tiotropium bromide inhalation spray
Dosage form
SPRAY, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA021936
Marketing category
NDA
Marketing start
2014-09-30
Substance
TIOTROPIUM BROMIDE ANHYDROUS
Active strength
3.124 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 Respimat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOTROPIUM BROMIDE ANHYDROUS3.124 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX112XZP0J
Rxcui1552002, 1552004, 1552008, 1552009, 1667880, 1667882, 1667885, 1667886, 2166203, 2166204

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
0597-0100-28Spiriva Respimat1 in 1 CARTONSPRAY, METERED114
0597-0100-28Spiriva Respimat28 in 1 CARTRIDGESPRAY, METERED2814
0597-0100-51Spiriva Respimat10 in 1 CARTRIDGESPRAY, METERED1014
0597-0100-51Spiriva Respimat1 in 1 CARTONSPRAY, METERED114
0597-0100-61Spiriva Respimat1 in 1 CARTONSPRAY, METERED114
0597-0100-61Spiriva Respimat60 in 1 CARTRIDGESPRAY, METERED6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0100-28GM - Gram0597-010090740b38-5cfb-4ecb-b071-02d87d929a8e12019-04-11
0597-0100-31GM - Gram0597-01001f4e279c-8a7c-4f94-8fa8-7a907627e67112014-11-05
0597-0100-51GM - Gram0597-010030469c19-e512-45fe-a3e2-d2be26e8653212019-05-02
0597-0100-61GM - Gram0597-0100cd907bab-e3b8-4133-9439-f456a4a3827b12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIOTROPIUM BROMIDEACTIVE INGREDIENTXX112XZP0JSPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
TIOTROPIUMACTIVE MOIETY0EB439235FSPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0100SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 6 package rows20250112_7b656b14-fcaa-2741-f6f0-e0be48971c02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667886Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667882Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
2166204Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552009Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552004Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
2166203tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUATPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667885tiotropium bromide 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667880tiotropium bromide 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552008tiotropium bromide 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552002tiotropium bromide 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSPSN7b656b14-fcaa-2741-f6f0-e0be48971c0214
216620410 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]SBD7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788628 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray [Spiriva]SBD7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200928 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]SBD7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788260 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray [Spiriva]SBD7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200460 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]SBD7b656b14-fcaa-2741-f6f0-e0be48971c0214
216620310 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788528 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation SpraySCD7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200828 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788060 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation SpraySCD7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200260 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD7b656b14-fcaa-2741-f6f0-e0be48971c0214
216620410 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
216620410 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788628 ACTUAT Spiriva 0.00125 MG/ACTUAT Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200928 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200928 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
166788260 ACTUAT Spiriva 0.00125 MG/ACTUAT Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200460 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
155200460 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation SpraySY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667886Spiriva Respimat 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667882Spiriva Respimat 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667886Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667882Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552009Spiriva Respimat 2.5 MCG (3.124 MCG tiotropium bromide) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552004Spiriva Respimat 2.5 MCG (3.124 MCG tiotropium bromide) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
2166204Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552009Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552004Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667885tiotropium 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667880tiotropium 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667880tiotropium 1.25 MCG/ACTUAT Metered Dose Inhalation Spray 60 ACTUATSSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1667885tiotropium 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552008tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spary, 28 ACTUATSSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
2166203tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY7b656b14-fcaa-2741-f6f0-e0be48971c0214
1552002tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSSY7b656b14-fcaa-2741-f6f0-e0be48971c0214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0100-28005970100281 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE1 cartridge2014-09-300000-00-00NoNoCurrent
0597-0100-51005970100511 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE1 cartridge2019-03-150000-00-00NoNoCurrent
0597-0100-61005970100611 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE1 cartridge2014-09-300000-00-00NoNoCurrent