Stiolto Respimat

Product NDC: 0597-0155
Requested package NDC: 0597-0155-31
11-digit product format: 005970155
Labeler code: 0597
Product ID: 0597-0155_79996212-633b-464e-9967-834039fb13a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tiotropium bromide and olodaterol
Dosage form: SPRAY, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA206756
Marketing category: NDA
Marketing start: 2015-05-21
Substance: OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE MONOHYDRATE
Active strength: 2.736; 3.124 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0597-0155	0597-0155-31	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0597-0155	0597-0155-31	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N206756-001	STIOLTO RESPIMAT	OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION		RLD, RS	2015-05-21

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206756-001	7396341	2026-10-10	Drug product, Delist requested	2015-06-10
N206756-001	7727984	2027-01-19	Drug substance	2015-06-10
N206756-001	9027967	2027-03-31	Drug product, Delist requested	2015-06-10
N206756-001	7396341*PED	2027-04-10	Pediatric extension
N206756-001	7837235	2028-03-13	Drug product, Delist requested	2015-06-10
N206756-001	7837235*PED	2028-09-13	Pediatric extension
N206756-001	8733341	2030-10-16	Drug product, Delist requested	2015-06-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206756-001	STIOLTO RESPIMAT	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH	SPRAY, METERED / INHALATION	RLD, RS	2015-05-21	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 610 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	N206756-001	7396341	2026-10-10		Drug product, Delist requested	2015-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	7727984	2027-01-19		Drug substance	2015-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	9027967	2027-03-31		Drug product, Delist requested	2015-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	7396341*PED	2027-04-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	7837235	2028-03-13		Drug product, Delist requested	2015-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	7837235*PED	2028-09-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206756-001	8733341	2030-10-16		Drug product, Delist requested	2015-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7284474	2024-08-26		Drug product	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7284474*PED	2025-02-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7220742	2025-05-12	U-1703	Drug substance, Drug product	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	8034809	2025-05-12	U-1702		2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7396341	2026-10-10		Drug product, Delist requested	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7727984	2027-01-19		Drug substance	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	9027967	2027-03-31		Drug product, Delist requested	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7396341*PED	2027-04-10		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7837235	2028-03-13		Drug product, Delist requested	2015-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	7837235*PED	2028-09-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206756-001	8733341	2030-10-16		Drug product, Delist requested	2015-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7284474*PED	2025-02-26		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7220742	2025-05-12	U-1703	Drug substance, Drug product	2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	8034809	2025-05-12	U-1702		2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7396341	2026-10-10		Drug product, Delist requested	2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7727984	2027-01-19		Drug substance	2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	9027967	2027-03-31		Drug product, Delist requested	2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7396341*PED	2027-04-10		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7837235	2028-03-13		Drug product, Delist requested	2015-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	7837235*PED	2028-09-13		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206756-001	8733341	2030-10-16		Drug product, Delist requested	2015-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7284474*PED	2025-02-26		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7220742	2025-05-12	U-1703	Drug substance, Drug product	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	8034809	2025-05-12	U-1702		2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7896264	2025-05-26		Drug product	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7396341	2026-10-10		Drug product	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7727984	2027-01-19		Drug substance	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	9027967	2027-03-31		Drug product	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7396341*PED	2027-04-10		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7837235	2028-03-13		Drug product	2015-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	7837235*PED	2028-09-13		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206756-001	8733341	2030-10-16		Drug product	2015-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206756-001	7284474*PED	2025-02-26		Pediatric extension		`b8a1b40f171c…`

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	N206756-001	M-173	2019-03-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206756-001	NCE	2019-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206756-001	M-233	2021-10-05	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N206756-001	M-233	2021-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206756-001	M-233	2021-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206756-001	M-233	2021-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206756-001	M-233	2021-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206756-001	M-233	2021-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206756-001	M-173	2019-03-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206756-001	NCE	2019-07-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206756-001	M-233	2021-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206756-001	M-173	2019-03-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206756-001	NCE	2019-07-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206756-001	M-233	2021-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206756-001	M-173	2019-03-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206756-001	NCE	2019-07-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206756-001	M-233	2021-10-05	`ea99ee380514…`

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
Stiolto Respimat	TIOTROPIUM BROMIDE AND OLODATEROL	Boehringer Ingelheim Pharmaceuticals, Inc.	01e15aee-40e0-23f3-537f-c96dd63e2cb1	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206756 application number: NDA206756 ndc (package): 0597-0155-31 ndc (product): 0597-0155 ndc11 (package): 00597015531

Additional Listing Data#

Finished product: Yes
Brand name base: Stiolto Respimat
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIOTROPIUM BROMIDE MONOHYDRATE	2.736 ug/1
OLODATEROL HYDROCHLORIDE	3.124 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L64SXO195N	Internal UNII lookup
65R445W3V9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1651266	Internal RxNorm lookup
1651271	Internal RxNorm lookup
1651274	Internal RxNorm lookup
1651275	Internal RxNorm lookup
2166927	Internal RxNorm lookup
2166928	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
01e15aee-40e0-23f3-537f-c96dd63e2cb1	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
2b29b33a-5f18-4409-a86e-fddfe3a86800	Product name	2	20141210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0597-0155-28	Stiolto Respimat	1 in 1 CARTON	SPRAY, METERED	1	16
0597-0155-28	Stiolto Respimat	28 in 1 CARTRIDGE	SPRAY, METERED	28	16
0597-0155-31	Stiolto Respimat	28 in 1 CARTRIDGE	SPRAY, METERED	28	16
0597-0155-31	Stiolto Respimat	1 in 1 CARTON	SPRAY, METERED	1	16
0597-0155-61	Stiolto Respimat	1 in 1 CARTON	SPRAY, METERED	1	16
0597-0155-61	Stiolto Respimat	60 in 1 CARTRIDGE	SPRAY, METERED	60	16
0597-0155-70	Stiolto Respimat	1 in 1 CARTON	SPRAY, METERED	1	16
0597-0155-70	Stiolto Respimat	10 in 1 CARTRIDGE	SPRAY, METERED	10	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0155-28	GM - Gram	0597-0155	c40d56af-ce77-4729-b882-58000d629f16	1	2026-02-05
0597-0155-31	GM - Gram	0597-0155	843e334d-cc87-40be-81a9-337b2092a3ce	1	2018-06-11
0597-0155-61	GM - Gram	0597-0155	ffba7a1c-e03a-44a0-80f1-d0c98b8e7950	1	2015-06-09
0597-0155-70	GM - Gram	0597-0155	19884256-f0bb-4fe1-a4c2-137b9d84e442	1	2019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLODATEROL HYDROCHLORIDE	ACTIVE INGREDIENT	65R445W3V9	STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	2
TIOTROPIUM BROMIDE MONOHYDRATE	ACTIVE INGREDIENT	L64SXO195N	STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	2
OLODATEROL	ACTIVE MOIETY	VD2YSN1AFD	STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	2
TIOTROPIUM	ACTIVE MOIETY	0EB439235F	STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) 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
0597-0155	STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 8 package rows	20250305_01e15aee-40e0-23f3-537f-c96dd63e2cb1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
65R445W3V9	OLODATEROL HYDROCHLORIDE	869477-96-3	OLODATEROL HYDROCHLORIDE
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
2166928	Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 10 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651271	Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 28 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651275	Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 60 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651266	tiotropium 2.5 MCG / olodaterol 2.5 MCG per ACTUAT Metered Dose Inhalation Spray 28 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166927	tiotropium 2.5 MCG / olodaterol 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651274	tiotropium bromide 2.5 MCG / olodaterol 2.5 MCG per INHAL Metered Dose Inhalation Spray, 60 ACTUAT	PSN	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166928	10 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]	SBD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651271	28 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]	SBD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651275	60 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Stiolto]	SBD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166927	10 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651266	28 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651274	60 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray	SCD	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166927	olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651266	olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651274	olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166927	olodaterol 2.5 MCG / tiotropium 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651266	olodaterol 2.5 MCG / tiotropium 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166928	Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651271	Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651275	Stiolto Respimat 2.5 MCG/2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
2166928	Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 10 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651271	Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16
1651275	Stiolto Respimat 2.5/2.5 olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT	SY	01e15aee-40e0-23f3-537f-c96dd63e2cb1	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0155-31	00597015531	1 CARTRIDGE in 1 CARTON (0597-0155-31) > 28 SPRAY, METERED in 1 CARTRIDGE	1 cartridge	2018-07-02	2021-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stiolto Respimat	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| Boehringer Ingelheim España, S.A.	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	16