Home NDC 0597-0192 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203108-001 STRIVERDI RESPIMAT OLODATEROL HYDROCHLORIDE EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-07-31
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203108-001 7727984 2027-01-19 Drug substance 2014-08-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N203108-001 STRIVERDI RESPIMAT EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-07-31 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N203108-001 7727984 2027-01-19 Drug substance 2014-08-15 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Striverdi Respimat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLODATEROL HYDROCHLORIDE 2.5 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 65R445W3V9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1546082 Internal RxNorm lookup 1546083 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0192-61 Striverdi Respimat 60 in 1 CARTRIDGE SPRAY, METERED 60 9 0597-0192-61 Striverdi Respimat 1 in 1 CARTON SPRAY, METERED 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Olodaterol hydrochloride ACTIVE INGREDIENT 65R445W3V9 STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 Olodaterol ACTIVE MOIETY VD2YSN1AFD STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0192 STRIVERDI RESPIMAT (OLODATEROL RESPIMAT INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250114_5d9a5433-857e-44ea-b3d6-2a400ca0cef5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0192-61 00597019261 1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE 1 cartridge 2014-08-01 0000-00-00 No No Current