FDA.reportPublic FDA data

Striverdi Respimat

Product NDC
0597-0192
11-digit product format
005970192
Labeler code
0597
Product ID
0597-0192_376b43be-46b2-49d7-bc0f-a6408571efea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olodaterol respimat inhalation spray
Dosage form
SPRAY, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA203108
Marketing category
NDA
Marketing start
2014-08-01
Substance
OLODATEROL HYDROCHLORIDE
Active strength
2.5 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [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
Striverdi Respimat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLODATEROL HYDROCHLORIDE2.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii65R445W3V9
Rxcui1546082, 1546083

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b2bc1652-3709-4d21-bd76-c433f7f7103eProduct name120150610
2b29b33a-5f18-4409-a86e-fddfe3a86800Product name220141210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0192-61Striverdi Respimat60 in 1 CARTRIDGESPRAY, METERED609
0597-0192-61Striverdi Respimat1 in 1 CARTONSPRAY, METERED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0192-31GM - Gram0597-01927ea47a79-1f11-4001-ad2a-3b22cbaeb3d512014-09-03
0597-0192-61GM - Gram0597-01920c758462-ddde-47c0-9551-5e4b44b78bcb12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Olodaterol hydrochlorideACTIVE INGREDIENT65R445W3V9STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
OlodaterolACTIVE MOIETYVD2YSN1AFDSTRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSTRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSTRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSTRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0192STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250114_5d9a5433-857e-44ea-b3d6-2a400ca0cef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546082olodaterol 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATPSN5d9a5433-857e-44ea-b3d6-2a400ca0cef59
1546083Striverdi Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATPSN5d9a5433-857e-44ea-b3d6-2a400ca0cef59
154608360 ACTUAT olodaterol 0.0025 MG/ACTUAT Inhalation Spray [Striverdi]SBD5d9a5433-857e-44ea-b3d6-2a400ca0cef59
154608260 ACTUAT olodaterol 0.0025 MG/ACTUAT Inhalation SpraySCD5d9a5433-857e-44ea-b3d6-2a400ca0cef59
154608260 ACTUAT olodaterol 0.0025 MG/ACTUAT Metered Dose Inhalation SpraySY5d9a5433-857e-44ea-b3d6-2a400ca0cef59
154608360 ACTUAT Striverdi 0.0025 MG/ACTUAT Inhalation SpraySY5d9a5433-857e-44ea-b3d6-2a400ca0cef59
154608360 ACTUAT Striverdi 0.0025 MG/ACTUAT Metered Dose Inhalation SpraySY5d9a5433-857e-44ea-b3d6-2a400ca0cef59
1546083Striverdi 2.5 MCG/ACTUAT (as olodaterol HCl 2.7 MCG/ACTUAT from mouthpiece) Metered Dose Inhalation Spray, 60 ACTUATSY5d9a5433-857e-44ea-b3d6-2a400ca0cef59
1546083Striverdi 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATSY5d9a5433-857e-44ea-b3d6-2a400ca0cef59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0192-61005970192611 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE1 cartridge2014-08-010000-00-00NoNoCurrent