BEVESPI AEROSPHERE

Product NDC: 0310-4600
11-digit product format: 003104600
Labeler code: 0310
Product ID: 0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate and formoterol fumarate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA208294
Marketing category: NDA
Marketing start: 2016-10-03
Substance: FORMOTEROL FUMARATE; GLYCOPYRROLATE
Active strength: 4.8; 9 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0310-4600	0310-4600-28	D	Discontinued by firm		2026-08-03
excluded package	package	0310-4600	0310-4600-39	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0310-4600-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0310-4600-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0310-4600-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0310-4600-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0310-4600-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0310-4600-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0310-4600-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0310-4600-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0310-4600-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0310-4600-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0310-4600-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0310-4600-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0310-4600-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0310-4600-39	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0310-4600-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0310-4600-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0310-4600-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0310-4600-39	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0310-4600-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0310-4600-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0310-4600-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0310-4600-39	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0310-4600-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0310-4600-39	`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
N208294-001	BEVESPI AEROSPHERE	FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2016-04-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19
N208294-001	8324266	2030-05-28	U-2889		2016-05-20
N208294-001	8703806	2030-05-28	U-2889		2016-05-20
N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20
N208294-001	9415009	2030-05-28	U-2889		2016-09-08
N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25
N208294-001	8815258	2031-03-17	U-2889		2016-05-20

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	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208294-001	BEVESPI AEROSPHERE	0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2016-04-25	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 283 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	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208294-001	8815258	2031-03-17	U-2889		2016-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208294-001	8815258	2031-03-17	U-2889		2016-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208294-001	8815258	2031-03-17	U-2889		2016-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208294-001	8815258	2031-03-17	U-2889		2016-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	9463161	2030-05-28	U-2889	Drug product	2016-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208294-001	8815258	2031-03-17	U-2889		2016-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	10716753	2030-05-28	U-2889	Drug product	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	8324266	2030-05-28	U-2889		2016-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	8703806	2030-05-28	U-2889		2016-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	8808713	2030-05-28	U-2889	Drug product	2016-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208294-001	9415009	2030-05-28	U-2889		2016-09-08	`03ed91905a0d…`

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	N208294-001	NP	2019-04-25	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208294-001	NP	2019-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208294-001	NP	2019-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208294-001	NP	2019-04-25	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: BEVESPI AEROSPHERE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCOPYRROLATE	4.8 ug/1
FORMOTEROL FUMARATE	9 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V92SO9WP2I	Internal UNII lookup
W34SHF8J2K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790639	Internal RxNorm lookup
1790644	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
ae02436e-9528-490e-a844-0c0f6f2843f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
138c3de2-4b03-4255-92b5-f022482d81bc	Product name	4	20260113
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e	Product name	5	20250304
0c06c4f4-ea2d-4e6a-a22a-0cf292716367	Product name	4	20250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b	Product name	1	20231002
76dcac30-469f-4f92-9c55-70950d209446	Product name	1	20230809
132196a6-5117-4b6e-a9dd-27f2793580c6	Product name	1	20230112
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
ac1f888b-a1db-4d2e-abbc-973f21c2ce1b	Product name	1	20220720
d84dd569-7bf0-1410-25eb-017ef37dd406	Product name	9	20210902
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
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
58b12de9-b891-41c7-9be6-ff47de5ec28b	Product name	1	20180828
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
9aff7b10-8e47-4b10-9a92-803440a37ce2	Product name	1	20180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a	Product name	1	20151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6	Product name	1	20151109
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
29ae08d1-069f-9822-4820-152d5dc67797	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-4600-12	BEVESPI AEROSPHERE	120 in 1 INHALER	AEROSOL, METERED	120	26
0310-4600-28	BEVESPI AEROSPHERE	28 in 1 INHALER	AEROSOL, METERED	28	26
0310-4600-39	BEVESPI AEROSPHERE	28 in 1 INHALER	AEROSOL, METERED	28	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-4600-39	GM - Gram	0310-4600	2f53c90a-0bd8-476b-b9ef-7503429fa9aa	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-4600	BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]	24	Current NDC, Legacy NDC, 3 package rows	20241120_ae02436e-9528-490e-a844-0c0f6f2843f9.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
BEVESPI AEROSPHERE	GLYCOPYRROLATE AND FORMOTEROL FUMARATE	AstraZeneca Pharmaceuticals LP	ae02436e-9528-490e-a844-0c0f6f2843f9	2023-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208294 application number: NDA208294 ndc (product): 0310-4600

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790644	BEVESPI Aerosphere 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790639	glycopyrrolate/formoterol fumarate 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790644	120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Bevespi]	SBD	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790639	120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler	SCD	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790644	Bevespi 4.8/9 (formoterol fumarate / glycopyrrolate) Metered Dose Inhaler, 120 ACTUAT	SY	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790644	Bevespi 4.8/9 Metered Dose Inhaler, 120 ACTUAT	SY	ae02436e-9528-490e-a844-0c0f6f2843f9	26
1790639	formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler	SY	ae02436e-9528-490e-a844-0c0f6f2843f9	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-4600-12	00310460012	120 AEROSOL, METERED in 1 INHALER (0310-4600-12)	2016-10-03	0000-00-00	No	No	Current
0310-4600-28	00310460028	28 AEROSOL, METERED in 1 INHALER (0310-4600-28)	2017-05-01	0000-00-00	No	No	Current
0310-4600-39	00310460039	28 AEROSOL, METERED in 1 INHALER (0310-4600-39)	2017-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BEVESPI AEROSPHERE - AstraZeneca Pharmaceuticals LP	AstraZeneca Pharmaceuticals LP	2023-03-24	HUMAN PRESCRIPTION DRUG LABEL	26