FDA.reportPublic FDA data

Stiolto Respimat

Product NDC
0597-0155
11-digit product format
005970155
Labeler code
0597
Product ID
0597-0155_79996212-633b-464e-9967-834039fb13a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tiotropium bromide and olodaterol
Dosage form
SPRAY, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA206756
Marketing category
NDA
Marketing start
2015-05-21
Substance
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE
Active strength
2.736; 3.124 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-01550597-0155-31DDiscontinued by firm2026-07-31

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
N206756-001STIOLTO RESPIMATOLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDEEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-05-21

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206756-00173963412026-10-10Drug product, Delist requested2015-06-10
N206756-00177279842027-01-19Drug substance2015-06-10
N206756-00190279672027-03-31Drug product, Delist requested2015-06-10
N206756-0017396341*PED2027-04-10Pediatric extension
N206756-00178372352028-03-13Drug product, Delist requested2015-06-10
N206756-0017837235*PED2028-09-13Pediatric extension
N206756-00187333412030-10-16Drug product, Delist requested2015-06-10

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 22:54:322026-06N206756-001STIOLTO RESPIMATEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-05-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N206756-00173963412026-10-10Drug product, Delist requested2015-06-10a50c72e98297…
2026-08-01 22:54:322026-06N206756-00177279842027-01-19Drug substance2015-06-10a50c72e98297…
2026-08-01 22:54:322026-06N206756-00190279672027-03-31Drug product, Delist requested2015-06-10a50c72e98297…
2026-08-01 22:54:322026-06N206756-0017396341*PED2027-04-10Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206756-00178372352028-03-13Drug product, Delist requested2015-06-10a50c72e98297…
2026-08-01 22:54:322026-06N206756-0017837235*PED2028-09-13Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N206756-00187333412030-10-16Drug product, Delist requested2015-06-10a50c72e98297…

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
Stiolto RespimatTIOTROPIUM BROMIDE AND OLODATEROLBoehringer Ingelheim Pharmaceuticals, Inc.01e15aee-40e0-23f3-537f-c96dd63e2cb12025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 206756
application number: NDA206756
ndc (product): 0597-0155

Additional Listing Data#

Finished product
Yes
Brand name base
Stiolto Respimat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOTROPIUM BROMIDE MONOHYDRATE2.736 ug/1
OLODATEROL HYDROCHLORIDE3.124 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L64SXO195NInternal UNII lookup
65R445W3V9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1651266Internal RxNorm lookup
1651271Internal RxNorm lookup
1651274Internal RxNorm lookup
1651275Internal RxNorm lookup
2166927Internal RxNorm lookup
2166928Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01e15aee-40e0-23f3-537f-c96dd63e2cb1Available 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
2b29b33a-5f18-4409-a86e-fddfe3a86800Product name220141210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0155-28Stiolto Respimat1 in 1 CARTONSPRAY, METERED116
0597-0155-28Stiolto Respimat28 in 1 CARTRIDGESPRAY, METERED2816
0597-0155-31Stiolto Respimat28 in 1 CARTRIDGESPRAY, METERED2816
0597-0155-31Stiolto Respimat1 in 1 CARTONSPRAY, METERED116
0597-0155-61Stiolto Respimat1 in 1 CARTONSPRAY, METERED116
0597-0155-61Stiolto Respimat60 in 1 CARTRIDGESPRAY, METERED6016
0597-0155-70Stiolto Respimat1 in 1 CARTONSPRAY, METERED116
0597-0155-70Stiolto Respimat10 in 1 CARTRIDGESPRAY, METERED1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0155-28GM - Gram0597-0155c40d56af-ce77-4729-b882-58000d629f1612026-02-05
0597-0155-31GM - Gram0597-0155843e334d-cc87-40be-81a9-337b2092a3ce12018-06-11
0597-0155-61GM - Gram0597-0155ffba7a1c-e03a-44a0-80f1-d0c98b8e795012015-06-09
0597-0155-70GM - Gram0597-015519884256-f0bb-4fe1-a4c2-137b9d84e44212019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLODATEROL HYDROCHLORIDEACTIVE INGREDIENT65R445W3V9STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]2
TIOTROPIUM BROMIDE MONOHYDRATEACTIVE INGREDIENTL64SXO195NSTIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]2
OLODATEROLACTIVE MOIETYVD2YSN1AFDSTIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]2
TIOTROPIUMACTIVE MOIETY0EB439235FSTIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0155STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 8 package rows20250305_01e15aee-40e0-23f3-537f-c96dd63e2cb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166928Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 10 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651271Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 28 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651275Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 60 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651266tiotropium 2.5 MCG / olodaterol 2.5 MCG per ACTUAT Metered Dose Inhalation Spray 28 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
2166927tiotropium 2.5 MCG / olodaterol 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651274tiotropium bromide 2.5 MCG / olodaterol 2.5 MCG per INHAL Metered Dose Inhalation Spray, 60 ACTUATPSN01e15aee-40e0-23f3-537f-c96dd63e2cb116
216692810 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]SBD01e15aee-40e0-23f3-537f-c96dd63e2cb116
165127128 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]SBD01e15aee-40e0-23f3-537f-c96dd63e2cb116
165127560 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]SBD01e15aee-40e0-23f3-537f-c96dd63e2cb116
216692710 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD01e15aee-40e0-23f3-537f-c96dd63e2cb116
165126628 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD01e15aee-40e0-23f3-537f-c96dd63e2cb116
165127460 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation SpraySCD01e15aee-40e0-23f3-537f-c96dd63e2cb116
2166927olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651266olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651274olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
2166927olodaterol 2.5 MCG / tiotropium 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651266olodaterol 2.5 MCG / tiotropium 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
2166928Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651271Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651275Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
2166928Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 10 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651271Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116
1651275Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY01e15aee-40e0-23f3-537f-c96dd63e2cb116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0155-28005970155281 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE1 cartridge2015-05-210000-00-00NoNoCurrent
0597-0155-31005970155311 CARTRIDGE in 1 CARTON (0597-0155-31) > 28 SPRAY, METERED in 1 CARTRIDGE1 cartridge2018-07-022021-07-31NoNoCurrent
0597-0155-61005970155611 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE1 cartridge2015-05-210000-00-00NoNoCurrent
0597-0155-70005970155701 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGE1 cartridge2019-03-220000-00-00NoNoCurrent