Home NDC 50090-7645 Spiriva
Product NDC 50090-7645
11-digit product format 500907645
Labeler code 50090
Product ID 50090-7645_70e86c70-cb36-45d0-853c-9840b3dad9b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIOTROPIUM BROMIDE
Dosage form CAPSULE
Route ORAL; RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
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 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION AB RLD, RS 2004-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 10 · 377 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021395-001 8022082*PED 2026-07-19 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021395-001 8022082*PED 2026-07-19 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021395-001 8022082*PED 2026-07-19 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021395-001 8022082*PED 2026-07-19 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021395-001 8022082*PED 2026-07-19 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 8022082*PED 2026-07-19 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 7694676*PED 2027-09-12 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 8022082*PED 2026-07-19 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 7694676*PED 2027-09-12 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 8022082*PED 2026-07-19 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 7694676*PED 2027-09-12 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 8022082*PED 2026-07-19 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 7694676*PED 2027-09-12 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 8022082*PED 2026-07-19 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 7694676*PED 2027-09-12 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 8022082*PED 2026-07-19 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 7694676*PED 2027-09-12 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021395-001 9010323 2030-04-19 Drug product 2017-04-20 d8e5a09893c0…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50090-7645-0 Spiriva HandiHaler 10 in 1 BLISTER PACK CAPSULE 10 1 50090-7645-0 Spiriva HandiHaler 3 in 1 CARTON CAPSULE 3 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7645-0 50090764500 3 BLISTER PACK in 1 CARTON (50090-7645-0) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2025-08-29 No No Current