Spiriva Respimat

Product NDC: 0597-0100
11-digit product format: 005970100
Labeler code: 0597
Product ID: 0597-0100_e44a3eea-f679-45fc-994a-0e960975b36b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tiotropium bromide inhalation spray
Dosage form: SPRAY, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA021936
Marketing category: NDA
Marketing start: 2014-09-30
Substance: TIOTROPIUM BROMIDE ANHYDROUS
Active strength: 3.124 ug/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021936-001	SPIRIVA RESPIMAT	TIOTROPIUM BROMIDE	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION		RLD, RS	2014-09-24
N021936-002	SPIRIVA RESPIMAT	TIOTROPIUM BROMIDE	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION		RLD, RS	2015-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20
N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15
N021936-001	7396341*PED	2027-04-10	Pediatric extension
N021936-001	9027967*PED	2027-09-30	Pediatric extension
N021936-001	7837235	2028-03-13	Drug product, Delist requested	2014-10-20
N021936-001	7837235*PED	2028-09-13	Pediatric extension
N021936-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-15
N021936-001	8733341*PED	2031-04-16	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021936-001	SPIRIVA RESPIMAT	EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2014-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021936-002	SPIRIVA RESPIMAT	EQ 0.00125MG BASE/INH	SPRAY, METERED / INHALATION	RLD	2015-09-15	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,056 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	7396341*PED	2027-04-10	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	9027967*PED	2027-09-30	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	7837235	2028-03-13	Drug product, Delist requested	2014-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	7837235*PED	2028-09-13	Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021936-001	8733341*PED	2031-04-16	Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	7396341*PED	2027-04-10	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	9027967*PED	2027-09-30	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	7837235	2028-03-13	Drug product, Delist requested	2014-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	7837235*PED	2028-09-13	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021936-001	8733341*PED	2031-04-16	Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	7396341*PED	2027-04-10	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	9027967*PED	2027-09-30	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	7837235	2028-03-13	Drug product, Delist requested	2014-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	7837235*PED	2028-09-13	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021936-001	8733341*PED	2031-04-16	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7284474	2024-08-26	Drug product	2014-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7284474*PED	2025-02-26	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7396341*PED	2027-04-10	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	9027967*PED	2027-09-30	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7837235	2028-03-13	Drug product, Delist requested	2014-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	7837235*PED	2028-09-13	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-001	8733341*PED	2031-04-16	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-002	7284474	2024-08-26	Drug product	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021936-002	7284474*PED	2025-02-26	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021936-001	7284474*PED	2025-02-26	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021936-001	7396341	2026-10-10	Drug product, Delist requested	2014-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021936-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021936-001	7396341*PED	2027-04-10	Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021936-001	NPP	2020-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021936-001	PED	2020-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021936-002	PED	2019-03-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021936-002	NPP	2020-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021936-002	PED	2020-08-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021936-001	NPP	2020-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021936-001	PED	2020-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021936-002	NPP	2020-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021936-002	PED	2020-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021936-001	NPP	2020-02-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021936-001	PED	2020-08-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021936-002	NPP	2020-02-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021936-002	PED	2020-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021936-001	NPP	2020-02-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021936-001	PED	2020-08-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021936-002	PED	2019-03-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021936-002	NPP	2020-02-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021936-002	PED	2020-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021936-001	NPP	2020-02-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021936-001	PED	2020-08-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021936-002	PED	2019-03-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021936-002	NPP	2020-02-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021936-002	PED	2020-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021936-001	NPP	2020-02-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021936-001	PED	2020-08-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021936-002	PED	2019-03-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021936-002	NPP	2020-02-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021936-002	PED	2020-08-15	`ea99ee380514…`

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 Respimat
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIOTROPIUM BROMIDE ANHYDROUS	3.124 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XX112XZP0J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1552002	Internal RxNorm lookup
1552004	Internal RxNorm lookup
1552008	Internal RxNorm lookup
1552009	Internal RxNorm lookup
1667880	Internal RxNorm lookup
1667882	Internal RxNorm lookup
1667885	Internal RxNorm lookup
1667886	Internal RxNorm lookup
2166203	Internal RxNorm lookup
2166204	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
7b656b14-fcaa-2741-f6f0-e0be48971c02	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
0597-0100-28	Spiriva Respimat	1 in 1 CARTON	SPRAY, METERED	1	14
0597-0100-28	Spiriva Respimat	28 in 1 CARTRIDGE	SPRAY, METERED	28	14
0597-0100-51	Spiriva Respimat	10 in 1 CARTRIDGE	SPRAY, METERED	10	14
0597-0100-51	Spiriva Respimat	1 in 1 CARTON	SPRAY, METERED	1	14
0597-0100-61	Spiriva Respimat	1 in 1 CARTON	SPRAY, METERED	1	14
0597-0100-61	Spiriva Respimat	60 in 1 CARTRIDGE	SPRAY, METERED	60	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0100-28	GM - Gram	0597-0100	90740b38-5cfb-4ecb-b071-02d87d929a8e	1	2019-04-11
0597-0100-31	GM - Gram	0597-0100	1f4e279c-8a7c-4f94-8fa8-7a907627e671	1	2014-11-05
0597-0100-51	GM - Gram	0597-0100	30469c19-e512-45fe-a3e2-d2be26e86532	1	2019-05-02
0597-0100-61	GM - Gram	0597-0100	cd907bab-e3b8-4133-9439-f456a4a3827b	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TIOTROPIUM BROMIDE	ACTIVE INGREDIENT	XX112XZP0J	SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
TIOTROPIUM	ACTIVE MOIETY	0EB439235F	SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0100	SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE INHALATION SPRAY) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 6 package rows	20250112_7b656b14-fcaa-2741-f6f0-e0be48971c02.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spiriva Respimat	TIOTROPIUM BROMIDE INHALATION SPRAY	Boehringer Ingelheim Pharmaceuticals, Inc.	7b656b14-fcaa-2741-f6f0-e0be48971c02	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021936 application number: NDA021936 ndc (product): 0597-0100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XX112XZP0J	TIOTROPIUM BROMIDE ANHYDROUS	136310-93-5	TIOTROPIUM BROMIDE ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1667886	Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667882	Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166204	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166203	tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667885	tiotropium bromide 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATS	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667880	tiotropium bromide 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATS	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552008	tiotropium bromide 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATS	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552002	tiotropium bromide 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATS	PSN	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166204	10 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]	SBD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667886	28 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray [Spiriva]	SBD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	28 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]	SBD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667882	60 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray [Spiriva]	SBD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	60 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]	SBD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166203	10 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667885	28 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray	SCD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552008	28 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667880	60 ACTUAT tiotropium 0.00125 MG/ACTUAT Inhalation Spray	SCD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552002	60 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166204	10 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166204	10 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667886	28 ACTUAT Spiriva 0.00125 MG/ACTUAT Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	28 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	28 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667882	60 ACTUAT Spiriva 0.00125 MG/ACTUAT Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	60 ACTUAT Spiriva 0.0025 MG/ACTUAT Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	60 ACTUAT Spiriva 0.0025 MG/ACTUAT Metered Dose Inhalation Spray	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667886	Spiriva Respimat 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667882	Spiriva Respimat 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667886	Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667882	Spiriva Respimat 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	Spiriva Respimat 2.5 MCG (3.124 MCG tiotropium bromide) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	Spiriva Respimat 2.5 MCG (3.124 MCG tiotropium bromide) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166204	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552009	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552004	Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667885	tiotropium 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667880	tiotropium 1.25 MCG (as tiotropium bromide 1.562 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667880	tiotropium 1.25 MCG/ACTUAT Metered Dose Inhalation Spray 60 ACTUATS	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1667885	tiotropium 1.25 MCG/ACTUAT Metered Dose Inhalation Spray, 28 ACTUATS	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552008	tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spary, 28 ACTUATS	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
2166203	tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14
1552002	tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATS	SY	7b656b14-fcaa-2741-f6f0-e0be48971c02	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0100-28	00597010028	1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE	1 cartridge	2014-09-30	0000-00-00	No	No	Current
0597-0100-51	00597010051	1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE	1 cartridge	2019-03-15	0000-00-00	No	No	Current
0597-0100-61	00597010061	1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE	1 cartridge	2014-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tiotropium bromide inhalation spray	Boehringer Ingelheim Pharmaceuticals, Inc.	2026-08-17	HUMAN PRESCRIPTION DRUG LABEL	16