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 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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021395-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021395-001	AB	1	`caaa826d4ba7…`
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
820839ef-e53d-47e8-a3b9-d911ff92e6a9	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0075-41	EA - Each	0597-0075	3619c466-44bd-4ffe-9c7d-b4d0b8e71093	1	2012-07-24
0597-0075-47	EA - Each	0597-0075	572fc425-ddb1-4710-8180-c07a41cd2bc2	1	2012-07-24
0597-0075-75	EA - Each	0597-0075	1a8f804b-44c0-4591-bdc3-5d27c4976dce	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIOTROPIUM BROMIDE MONOHYDRATE	ACTIVE INGREDIENT	L64SXO195N	SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	18
TIOTROPIUM	ACTIVE MOIETY	0EB439235F	SPIRIVA (TIOTROPIUM BROMIDE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	18
TIOTROPIUM BROMIDE MONOHYDRATE	ACTIVE INGREDIENT	L64SXO195N	SPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TIOTROPIUM	ACTIVE MOIETY	0EB439235F	SPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3

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

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 ndc (product): 0597-0075
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	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
485032	tiotropium 18 MCG Inhalation Powder	PSN	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
580261	tiotropium 0.018 MG Inhalation Powder [Spiriva]	SBD	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
485032	tiotropium 0.018 MG Inhalation Powder	SCD	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
580261	Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
580261	Spiriva HandiHaler 18 MCG Inhalation Powder	SY	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
485032	tiotropium 18 MCG Inhalation Powder	SY	820839ef-e53d-47e8-a3b9-d911ff92e6a9	28
580261	SPIRIVA HandiHaler 18 MCG Inhalation Powder	PSN	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	SPIRIVA HandiHaler 18 MCG Inhalation Powder	PSN	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
485032	tiotropium 18 MCG Inhalation Powder	PSN	ba462261-734a-4e9f-a5c0-5c676bc56a2e	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
580261	tiotropium 0.018 MG Inhalation Powder [Spiriva]	SBD	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
485032	tiotropium 0.018 MG Inhalation Powder	SCD	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 0.018 MG Inhalation Powder	SCD	ba462261-734a-4e9f-a5c0-5c676bc56a2e	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 (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
580261	Spiriva HandiHaler 18 MCG Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	Spiriva HandiHaler 18 MCG Inhalation Powder	SY	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
485032	tiotropium 18 MCG Inhalation Powder	SY	ba462261-734a-4e9f-a5c0-5c676bc56a2e	3
485032	tiotropium 18 MCG Inhalation Powder	SY	25a4cb05-64a8-44b6-88c8-4292a5292e92	3
580261	SPIRIVA HandiHaler 18 MCG Inhalation Powder	PSN	c6343458-617b-41ed-8e96-763e91dc8e90	1
485032	tiotropium 18 MCG Inhalation Powder	PSN	c6343458-617b-41ed-8e96-763e91dc8e90	1
580261	tiotropium 0.018 MG Inhalation Powder [Spiriva]	SBD	c6343458-617b-41ed-8e96-763e91dc8e90	1
485032	tiotropium 0.018 MG Inhalation Powder	SCD	c6343458-617b-41ed-8e96-763e91dc8e90	1
580261	Spiriva HandiHaler 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	c6343458-617b-41ed-8e96-763e91dc8e90	1
580261	Spiriva HandiHaler 18 MCG Inhalation Powder	SY	c6343458-617b-41ed-8e96-763e91dc8e90	1
485032	tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder	SY	c6343458-617b-41ed-8e96-763e91dc8e90	1
485032	tiotropium 18 MCG Inhalation Powder	SY	c6343458-617b-41ed-8e96-763e91dc8e90	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spiriva HandiHaler - Boehringer Ingelheim Pharmaceuticals, Inc.	Boehringer Ingelheim Pharmaceuticals, Inc.	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	28
Spiriva HandiHaler - A-S Medication Solutions	A-S Medication Solutions	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	1
Spiriva HandiHaler - A-S Medication Solutions	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	3
Spiriva - A-S Medication Solutions	A-S Medication Solutions	2020-05-15	HUMAN PRESCRIPTION DRUG LABEL	3
Spiriva	Physicians Total Care, Inc.	2010-03-18	HUMAN PRESCRIPTION DRUG LABEL	3