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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLODATEROL HYDROCHLORIDE2.736 ug/1
TIOTROPIUM BROMIDE MONOHYDRATE3.124 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii65R445W3V9, L64SXO195N
Rxcui1651266, 1651271, 1651274, 1651275, 2166927, 2166928

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