BREZTRI

Product NDC: 0310-4616
11-digit product format: 003104616
Labeler code: 0310
Product ID: 0310-4616_2d00a029-b36a-4a4f-8583-1af78a184682
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide, glycopyrrolate, and formoterol fumarate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA212122
Marketing category: NDA
Marketing start: 2020-07-23
Substance: BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE
Active strength: 160; 4.8; 9 ug/1; ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212122-001	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2020-07-23
N212122-002	BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2026-04-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	8324266	2030-05-28	U-2889		2020-08-18
N212122-001	8703806	2030-05-28	U-2889		2020-08-18
N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	9415009	2030-05-28	U-2889		2020-08-18
N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18
N212122-001	8815258	2031-03-17	U-2889		2020-08-18
N212122-001	11331442	2038-10-05		Drug product	2022-06-16
N212122-001	11833292	2038-10-05		Drug product	2023-12-21
N212122-002	10716753	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	8324266	2030-05-28	U-4503		2026-05-19
N212122-002	8703806	2030-05-28	U-4503		2026-05-19
N212122-002	8808713	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	9415009	2030-05-28	U-4503		2026-05-19
N212122-002	9463161	2030-05-28	U-4503	Drug product	2026-05-19
N212122-002	8815258	2031-03-17	U-4503		2026-05-19
N212122-002	11331442	2038-10-05		Drug product	2026-05-19
N212122-002	11833292	2038-10-05		Drug product	2026-05-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212122-002	NS	2029-04-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-001	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.009MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2020-07-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-002	BREZTRI AEROSPHERE	0.16MG/INH;0.0048MG/INH;0.018MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2026-04-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	10716753	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8324266	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8703806	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8808713	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	9415009	2030-05-28	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	9463161	2030-05-28	U-4503	Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	8815258	2031-03-17	U-4503		2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	11331442	2038-10-05		Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212122-002	11833292	2038-10-05		Drug product	2026-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	9415009	2030-05-28	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	9463161	2030-05-28	U-2889	Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	8815258	2031-03-17	U-2889		2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	11331442	2038-10-05		Drug product	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212122-001	11833292	2038-10-05		Drug product	2023-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212122-001	10716753	2030-05-28	U-2889	Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8324266	2030-05-28	U-2889		2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8703806	2030-05-28	U-2889		2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212122-001	8808713	2030-05-28	U-2889	Drug product	2020-08-18	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N212122-002	NS	2029-04-27	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212122-001	NC	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212122-001	NC	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212122-001	NC	2023-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212122-001	NC	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212122-001	NC	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212122-001	NC	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212122-001	NC	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212122-001	NC	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212122-001	NC	2023-07-23	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N212122-001	NC	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212122-001	NC	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212122-001	NC	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212122-001	NC	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212122-001	NC	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212122-001	NC	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212122-001	NC	2023-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212122-001	NC	2023-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212122-001	NC	2023-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212122-001	NC	2023-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212122-001	NC	2023-07-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212122-002	NS	2029-04-27	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: BREZTRI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	160 ug/1
GLYCOPYRROLATE	4.8 ug/1
FORMOTEROL	9 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup
5ZZ84GCW8B	Internal UNII lookup
V92SO9WP2I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2387326	Internal RxNorm lookup
2387328	Internal RxNorm lookup
2387329	Internal RxNorm lookup
2387331	Internal RxNorm lookup
2741705	Internal RxNorm lookup
2741708	Internal RxNorm lookup
2741710	Internal RxNorm lookup
2741711	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
715433dc-cb2b-43ea-b6df-c5b4177adc6c	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
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
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
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
132196a6-5117-4b6e-a9dd-27f2793580c6	Product name	1	20230112
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
ac1f888b-a1db-4d2e-abbc-973f21c2ce1b	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
d84dd569-7bf0-1410-25eb-017ef37dd406	Product name	9	20210902
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
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
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106
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
0310-4616-12	BREZTRI	120 in 1 INHALER	AEROSOL, METERED	120	7
0310-4616-28	BREZTRI	28 in 1 INHALER	AEROSOL, METERED	28	7
0310-4616-39	BREZTRI	28 in 1 INHALER	AEROSOL, METERED	28	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-4616-12	GM - Gram	0310-4616	82127501-61a2-446a-93a2-b44360a1ea72	1	2020-08-06
0310-4616-28	GM - Gram	0310-4616	f9bce7a1-ffac-4b63-82af-30ac7975e93a	1	2021-06-02
0310-4616-39	GM - Gram	0310-4616	8502c568-739a-4296-91d2-01f736457c24	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-4616	BREZTRI (BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]	5	Current NDC, Legacy NDC, 3 package rows	20241013_715433dc-cb2b-43ea-b6df-c5b4177adc6c.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
BREZTRI	BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE	AstraZeneca Pharmaceuticals LP	715433dc-cb2b-43ea-b6df-c5b4177adc6c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212122 application number: NDA212122 ndc (product): 0310-4616

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE
5ZZ84GCW8B	FORMOTEROL	73573-87-2	FORMOTEROL
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2741711	BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741708	BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 28 Actuations	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387328	BREZTRI 160/9/4.8 MCG INHAL Metered Dose Inhaler, 28 Actuations	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387331	BREZTRI 160/9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387329	budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387326	budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741710	budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose Inhaler	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741705	budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose Inhaler	PSN	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387331	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]	SBD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741711	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri]	SBD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387328	28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]	SBD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741708	28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri]	SBD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387329	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler	SCD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741710	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler	SCD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387326	28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler	SCD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741705	28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler	SCD	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387331	BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387328	BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUAT	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741711	BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741708	BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUAT	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387329	budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2387326	budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741710	budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose Inhaler	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7
2741705	budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose Inhaler	SY	715433dc-cb2b-43ea-b6df-c5b4177adc6c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-4616-12	00310461612	120 AEROSOL, METERED in 1 INHALER (0310-4616-12)	2020-07-23	0000-00-00	No	No	Current
0310-4616-28	00310461628	28 AEROSOL, METERED in 1 INHALER (0310-4616-28)	2020-07-23	0000-00-00	Yes	No	Current
0310-4616-39	00310461639	28 AEROSOL, METERED in 1 INHALER (0310-4616-39)	2020-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BREZTRI - AstraZeneca Pharmaceuticals LP	AstraZeneca Pharmaceuticals LP	2026-04-27	HUMAN PRESCRIPTION DRUG LABEL	9