Tudorza Pressair

Product NDC: 70515-002
11-digit product format: 705150002
Labeler code: 70515
Product ID: 70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aclidinium bromide
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Covis Pharma US, Inc
Application: NDA202450
Marketing category: NDA
Marketing start: 2015-07-01
Substance: ACLIDINIUM BROMIDE
Active strength: 400 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
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.

Additional Listing Data#

Finished product: Yes
Brand name base: Tudorza Pressair
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACLIDINIUM BROMIDE	400 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UQW7UF9N91	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1303102	Internal RxNorm lookup
1303107	Internal RxNorm lookup
1607111	Internal RxNorm lookup
1607112	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
6f92cceb-a63f-4470-99b6-56179d98f10f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f15a44-d9d2-4d61-a39d-7f0223302a8f	Product name	1	20190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70515-002-01	Tudorza Pressair	1 in 1 POUCH	POWDER, METERED	1	2
70515-002-01	Tudorza Pressair	1 in 1 CARTON	POWDER, METERED	1	2
70515-002-02	Tudorza Pressair	1 in 1 CARTON	POWDER, METERED	1	2
70515-002-02	Tudorza Pressair	1 in 1 POUCH	POWDER, METERED	1	2
70515-002-03	Tudorza Pressair	1 in 1 CARTON	POWDER, METERED	1	2
70515-002-03	Tudorza Pressair	1 in 1 POUCH	POWDER, METERED	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-002-01	EA - Each	70515-002	2122c300-9dd6-4ec3-b013-efee0f220d72	1	2023-12-05
70515-002-02	EA - Each	70515-002	abcdc433-b31c-4b49-a8ee-c61ddab29af0	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-002	TUDORZA PRESSAIR (ACLIDINIUM BROMIDE) POWDER, METERED [COVIS PHARMA US, INC]	2	Current NDC, 6 package rows	20231208_6f92cceb-a63f-4470-99b6-56179d98f10f.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
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 ndc (product): 70515-002

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1607111	aclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT	PSN	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303102	aclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607112	Tudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT	PSN	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303107	Tudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607112	30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [Tudorza]	SBD	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303107	60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler [Tudorza]	SBD	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607111	30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler	SCD	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303102	60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler	SCD	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607112	30 ACTUAT Tudorza 0.4 MG/ACTUAT Dry Powder Inhaler	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303102	60 ACTUAT aclidinium bromide 400 MCG/ACTUAT Dry Powder Inhaler	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303107	60 ACTUAT Tudorza 0.4 MG/ACTUAT Dry Powder Inhaler	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303102	aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607111	aclidinium bromide 400 MCG/ACTUAT (375 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 30 ACTUAT	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303107	Tudorza 400 MCG/ACTUAT (aclidinium bromide 375 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 60 ACTUAT	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1303107	Tudorza 400 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2
1607112	Tudorza Pressair 400 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAT	SY	6f92cceb-a63f-4470-99b6-56179d98f10f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70515-002-01	70515000201	1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	No	No	Current
70515-002-02	70515000202	1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	No	No	Current
70515-002-03	70515000203	1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	1 pouch	2015-07-01	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tudorza Pressair - Covis Pharma US, Inc	Covis Pharma US, Inc	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2