Tudorza Pressair

Product NDC: 0310-0800
11-digit product format: 003100800
Labeler code: 0310
Product ID: 0310-0800_4e3ae998-ea80-4478-9ba1-ab36d05e1cc4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aclidinium bromide
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA202450
Marketing category: NDA
Marketing start: 2015-07-01
Marketing end: 2024-07-31
Substance: ACLIDINIUM BROMIDE
Active strength: 400 ug/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0310-0800		D	Discontinued by firm	2026-10-05
excluded package	package	0310-0800	0310-0800-39	D	Discontinued by firm	2026-10-05
excluded package	package	0310-0800	0310-0800-60	D	Discontinued by firm	2026-10-05
excluded package	package	0310-0800	0310-0800-95	D	Discontinued by firm	2026-10-05

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 · 46 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-0800-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-0800-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-0800-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-0800-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-0800-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-0800-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-0800-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-0800-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-0800-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-0800-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-0800-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-0800-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-0800-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-0800-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-0800-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-0800-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-0800-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-0800-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-0800-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-0800-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-0800-39	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-0800-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-0800-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-0800-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-0800-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-0800-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-0800-39	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-0800-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-0800-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-0800-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0800-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0800-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0800-39	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-0800-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-0800-39	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N202450-001	TUDORZA PRESSAIR	ACLIDINIUM BROMIDE	0.4MG/INH	POWDER, METERED / INHALATION		RLD, RS	2012-07-23

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
N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26
N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10

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 · 43 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	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202450-001	TUDORZA PRESSAIR	0.4MG/INH	POWDER, METERED / INHALATION	RLD, RS	2012-07-23	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 202 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	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	10085974	2029-03-13	U-2513	Drug product	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202450-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202450-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2017-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202450-001	8051851	2027-04-22		Drug product	2012-08-17	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202450-001	M-256	2022-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202450-001	M-256	2022-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202450-001	M-256	2022-03-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202450-001	M-256	2022-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202450-001	M-256	2022-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202450-001	M-256	2022-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202450-001	M-256	2022-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202450-001	M-256	2022-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202450-001	M-256	2022-03-29	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N202450-001	M-256	2022-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202450-001	M-256	2022-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202450-001	M-256	2022-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202450-001	M-256	2022-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202450-001	M-256	2022-03-29	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0800-39	EA - Each	0310-0800	5e52b7e7-4a7b-46ba-825c-c715877dd44e	1	2015-07-20
0310-0800-60	EA - Each	0310-0800	c9125009-cdad-4ff1-8937-4094bcc17cbb	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACLIDINIUM BROMIDE	ACTIVE INGREDIENT	UQW7UF9N91	TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) INHALANT [ASTRAZENECA PHARMACEUTICALS LP]	2
aclidinium bromide	ACTIVE MOIETY	UQW7UF9N91	TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) INHALANT [ASTRAZENECA PHARMACEUTICALS LP]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) INHALANT [ASTRAZENECA PHARMACEUTICALS LP]	2

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
Tudorza Pressair	ACLIDINIUM BROMIDE	Covis Pharma US, Inc	6f92cceb-a63f-4470-99b6-56179d98f10f	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202450 application number: NDA202450

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UQW7UF9N91	ACLIDINIUM BROMIDE	320345-99-1	ACLIDINIUM BROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-0800-39	00310080039	1 POUCH in 1 CARTON (0310-0800-39) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	0000-00-00	No	No	Current
0310-0800-60	00310080060	1 POUCH in 1 CARTON (0310-0800-60) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	0000-00-00	No	No	Current
0310-0800-95	00310080095	1 POUCH in 1 CARTON (0310-0800-95) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tudorza Pressair - AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	22