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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021936-001SPIRIVA RESPIMATTIOTROPIUM BROMIDEEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24
N021936-002SPIRIVA RESPIMATTIOTROPIUM BROMIDEEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021936-00173963412026-10-10Drug product, Delist requested2014-10-20
N021936-00190279672027-03-31Drug product, Delist requested2015-09-15
N021936-0017396341*PED2027-04-10Pediatric extension
N021936-0019027967*PED2027-09-30Pediatric extension
N021936-00178372352028-03-13Drug product, Delist requested2014-10-20
N021936-0017837235*PED2028-09-13Pediatric extension
N021936-00187333412030-10-16Drug product, Delist requested2015-09-15
N021936-0018733341*PED2031-04-16Pediatric 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 22:54:322026-06N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24a50c72e98297…
2026-08-01 22:54:322026-06N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021936-00173963412026-10-10Drug product, Delist requested2014-10-20a50c72e98297…
2026-08-01 22:54:322026-06N021936-00190279672027-03-31Drug product, Delist requested2015-09-15a50c72e98297…
2026-08-01 22:54:322026-06N021936-0017396341*PED2027-04-10Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N021936-0019027967*PED2027-09-30Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N021936-00178372352028-03-13Drug product, Delist requested2014-10-20a50c72e98297…
2026-08-01 22:54:322026-06N021936-0017837235*PED2028-09-13Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N021936-00187333412030-10-16Drug product, Delist requested2015-09-15a50c72e98297…
2026-08-01 22:54:322026-06N021936-0018733341*PED2031-04-16Pediatric 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spiriva RespimatTIOTROPIUM BROMIDE INHALATION SPRAYBoehringer Ingelheim Pharmaceuticals, Inc.7b656b14-fcaa-2741-f6f0-e0be48971c022025-11-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021936
application number: NDA021936
ndc (product): 0597-0100

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XX112XZP0JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1552002Internal RxNorm lookup
1552004Internal RxNorm lookup
1552008Internal RxNorm lookup
1552009Internal RxNorm lookup
1667880Internal RxNorm lookup
1667882Internal RxNorm lookup
1667885Internal RxNorm lookup
1667886Internal RxNorm lookup
2166203Internal RxNorm lookup
2166204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b656b14-fcaa-2741-f6f0-e0be48971c02Available 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

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