Home NDC 0597-0075 Spiriva
Product NDC 0597-0075
11-digit product format 005970075
Labeler code 0597
Product ID 0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIOTROPIUM BROMIDE
Dosage form CAPSULE
Route ORAL; RESPIRATORY (INHALATION)
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA021395
Marketing category NDA
Marketing start 2005-10-11
Substance TIOTROPIUM BROMIDE MONOHYDRATE
Active strength 18 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021395-001 SPIRIVA TIOTROPIUM BROMIDE EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021395-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 N021395-001 8022082*PED 2026-07-19 Pediatric 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 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 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021395-001 AB 1 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 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021395-001 8022082*PED 2026-07-19 Pediatric extension 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Spiriva
Brand name suffix HandiHaler
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L64SXO195N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485032 Internal RxNorm lookup 580261 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 0597-0075-41 SpirivaHandiHaler 10 in 1 BLISTER PACK CAPSULE 10 28 0597-0075-41 SpirivaHandiHaler 3 in 1 CARTON CAPSULE 3 28 0597-0075-47 SpirivaHandiHaler 10 in 1 BLISTER PACK CAPSULE 10 28 0597-0075-47 SpirivaHandiHaler 9 in 1 CARTON CAPSULE 9 28 0597-0075-75 SpirivaHandiHaler 1 in 1 CARTON CAPSULE 1 28 0597-0075-75 SpirivaHandiHaler 5 in 1 BLISTER PACK CAPSULE 5 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0075 SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 27 Current NDC, Legacy NDC, 6 package rows 20250112_820839ef-e53d-47e8-a3b9-d911ff92e6a9.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 0597-0075-41 00597007541 3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2005-10-11 0000-00-00 No No Current 0597-0075-47 00597007547 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK 9 blister pack 2005-10-11 0000-00-00 No No Current 0597-0075-75 00597007575 1 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACK 1 blister pack 2005-10-11 0000-00-00 No No Current