Spiriva

Product NDC: 50090-4414
Requested package NDC: 50090-4414-0
11-digit product format: 500904414
Labeler code: 50090
Product ID: 50090-4414_22fe8b5c-76a9-407d-9fec-9761e54555eb
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
Marketing end: 0000-00-00
Substance: TIOTROPIUM BROMIDE MONOHYDRATE
Active strength: 18 ug/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4414	50090-4414-0	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021395-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021395-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021395-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021395-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021395-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021395-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021395-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021395-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021395-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021395-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021395-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021395-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021395-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021395-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021395-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021395-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021395-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021395-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021395-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021395-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021395-001	AB	1	`a50c72e98297…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48c4d28d-b099-457f-b725-6536a67545d9	Product name	1	20240723
e5bad22a-8b64-476c-b12b-bcb1efd8adfc	Product name	3	20210727
b2bc1652-3709-4d21-bd76-c433f7f7103e	Product name	1	20150610

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4414-0	2023-01-30	C162847	48780-1	f386c649-ea5e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4414-0	Spiriva	9 in 1 CARTON	CAPSULE	9		3
50090-4414-0	Spiriva	10 in 1 BLISTER PACK	CAPSULE	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4414-0	EA - Each	50090-4414	bdef023d-1f60-4df5-b4d1-b0a60a4d62a4	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4414	SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20200516_25a4cb05-64a8-44b6-88c8-4292a5292e92.zip

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spiriva HandiHaler	TIOTROPIUM BROMIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	820839ef-e53d-47e8-a3b9-d911ff92e6a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021395 application number: NDA021395
Spiriva HandiHaler	TIOTROPIUM BROMIDE	A-S Medication Solutions	c6343458-617b-41ed-8e96-763e91dc8e90	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021395 application number: NDA021395
Spiriva HandiHaler	TIOTROPIUM BROMIDE	A-S Medication Solutions	ba462261-734a-4e9f-a5c0-5c676bc56a2e	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021395 application number: NDA021395

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L64SXO195N	TIOTROPIUM BROMIDE MONOHYDRATE	411207-31-3	TIOTROPIUM BROMIDE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
580261	SPIRIVA HandiHaler 18 MCG Inhalation Powder	PSN	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 18 MCG Inhalation Powder	PSN	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	tiotropium 0.018 MG Inhalation Powder [Spiriva]	SBD	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 0.018 MG Inhalation Powder	SCD	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	Spiriva HandiHaler 18 MCG Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 18 MCG Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4414-0	50090441400	9 BLISTER PACK in 1 CARTON (50090-4414-0) > 10 CAPSULE in 1 BLISTER PACK	9 blister pack	2019-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spiriva - A-S Medication Solutions	A-S Medication Solutions	2020-05-15	HUMAN PRESCRIPTION DRUG LABEL	3