Home NDC 50090-4248 Spiriva
Product NDC 50090-4248
11-digit product format 500904248
Labeler code 50090
Product ID 50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76
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 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.
Product history page 1 of 2 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021395-001 SPIRIVA EQ 0.018MG BASE/INH POWDER / INHALATION RLD, RS 2004-01-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 10 · 373 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-10-29 15:01 UTC 2024-10 N021395-001 8022082 2026-01-19 U-1186 Drug product 2011-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021395-001 8022082*PED 2026-07-19 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021395-001 7694676 2027-03-12 Drug product 2011-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021395-001 7694676*PED 2027-09-12 Pediatric extension d06236e962d9…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4248-0 Spiriva HandiHaler 10 in 1 BLISTER PACK CAPSULE 10 3 50090-4248-0 Spiriva HandiHaler 3 in 1 CARTON CAPSULE 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4248 SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 2 package rows 20230208_ba462261-734a-4e9f-a5c0-5c676bc56a2e.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 50090-4248-0 50090424800 3 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2019-04-02 0000-00-00 No No Current