DUAKLIR PRESSAIR

Product NDC: 70515-001
11-digit product format: 705150001
Labeler code: 70515
Product ID: 70515-001_2eba3089-28b4-4190-9fba-2511246cfd16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aclidinium bromide and formoterol fumarate
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Covis Pharma US, Inc
Application: NDA210595
Marketing category: NDA
Marketing start: 2019-03-29
Substance: ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Active strength: 400; 12 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

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
N210595-001	DUAKLIR PRESSAIR	ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		RLD, RS	2019-03-29

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
N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24
N210595-001	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	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION		2019-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210595-001	DUAKLIR PRESSAIR	0.4MG/INH;0.012MG/INH	POWDER, METERED / INHALATION	RLD, RS	2019-03-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 214 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	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210595-001	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	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210595-001	11000517	2029-03-13	U-2513	Drug product	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	10085974	2029-03-13	U-2513	Drug product	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210595-001	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	N210595-001	RE46417	2025-02-10	U-2513	Drug substance, Drug product	2019-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210595-001	8051851	2027-04-22		Drug product	2019-04-24	`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	N210595-001	NC	2022-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210595-001	NC	2022-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210595-001	NC	2022-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210595-001	NC	2022-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210595-001	NC	2022-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210595-001	NC	2022-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210595-001	NC	2022-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210595-001	NC	2022-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210595-001	NC	2022-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210595-001	NC	2022-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210595-001	NC	2022-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210595-001	NC	2022-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210595-001	NC	2022-03-29	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N210595-001	NC	2022-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210595-001	NC	2022-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210595-001	NC	2022-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210595-001	NC	2022-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210595-001	NC	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: DUAKLIR PRESSAIR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACLIDINIUM BROMIDE	400 ug/1
FORMOTEROL FUMARATE	12 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UQW7UF9N91	Internal UNII lookup
W34SHF8J2K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2205094	Internal RxNorm lookup
2205099	Internal RxNorm lookup
2205103	Internal RxNorm lookup
2205104	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
2eba3089-28b4-4190-9fba-2511246cfd16	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367	Product name	4	20250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
58f15a44-d9d2-4d61-a39d-7f0223302a8f	Product name	1	20190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70515-001-01	DUAKLIR PRESSAIR	1 in 1 CARTON	POWDER, METERED	1	1
70515-001-01	DUAKLIR PRESSAIR	1 in 1 POUCH	POWDER, METERED	1	1
70515-001-03	DUAKLIR PRESSAIR	1 in 1 CARTON	POWDER, METERED	1	1
70515-001-03	DUAKLIR PRESSAIR	1 in 1 POUCH	POWDER, METERED	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-001-01	EA - Each	70515-001	0cc3d7e7-dfdd-45a9-a831-fe1f884dbac4	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-001	DUAKLIR PRESSAIR (ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE) POWDER, METERED [COVIS PHARMA US, INC]	1	Current NDC, 4 package rows	20231208_2eba3089-28b4-4190-9fba-2511246cfd16.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
DUAKLIR PRESSAIR	ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE	Covis Pharma US, Inc	2eba3089-28b4-4190-9fba-2511246cfd16	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210595 application number: NDA210595 ndc (product): 70515-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UQW7UF9N91	ACLIDINIUM BROMIDE	320345-99-1	ACLIDINIUM BROMIDE
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2205103	aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 30 Actuations	PSN	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205094	aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations	PSN	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205104	Duaklir Pressair 400/12 MCG/INHAL Dry Powder Inhaler, 30 Actuations	PSN	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205099	Duaklir Pressair 400/12 MCG/INHAL Dry Powder Inhaler, 60 Actuations	PSN	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205104	30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [Duaklir]	SBD	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205099	60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [Duaklir]	SBD	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205103	30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler	SCD	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205094	60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler	SCD	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205104	Duaklir Pressair 400/12 ( aclidinium bromide 400 MCG/ formoterol fumarate 12 MCG ) per ACTUAT Dry Powder Inhaler, 30 Actuations	SY	2eba3089-28b4-4190-9fba-2511246cfd16	1
2205099	Duaklir Pressair 400/12 ( aclidinium bromide 400 MCG/ formoterol fumarate 12 MCG ) per ACTUAT Dry Powder Inhaler, 60 Actuations	SY	2eba3089-28b4-4190-9fba-2511246cfd16	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70515-001-01	70515000101	1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	1 pouch	2019-03-29	No	No	Current
70515-001-03	70515000103	1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	1 pouch	2019-03-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUAKLIR PRESSAIR - Covis Pharma US, Inc	Covis Pharma US, Inc	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	1