BREYNA

Product NDC: 0378-7503
11-digit product format: 003787503
Labeler code: 0378
Product ID: 0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide and Formoterol Fumarate
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA211699
Marketing category: ANDA
Marketing start: 2023-07-31
Substance: BUDESONIDE; FORMOTEROL FUMARATE
Active strength: 160; 4.5 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [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 43.

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
A211699-001	BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB		2022-03-15
A211699-002	BREYNA	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB		2022-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211699-001	AB
A211699-002	AB

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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211699-001	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211699-002	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211699-001	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211699-002	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211699-001	BREYNA	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211699-002	BREYNA	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	2022-03-15	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211699-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211699-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211699-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211699-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211699-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211699-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211699-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211699-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211699-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211699-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211699-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211699-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211699-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211699-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211699-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211699-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211699-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211699-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211699-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211699-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211699-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211699-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211699-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211699-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211699-002	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211699-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211699-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211699-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211699-002	AB	1	`1c564ffb4f44…`

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: BREYNA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	160 ug/1
FORMOTEROL FUMARATE	4.5 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	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
1246288	Internal RxNorm lookup
1246304	Internal RxNorm lookup
2597670	Internal RxNorm lookup
2597673	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
dc529fc4-bddb-4673-8202-dc401f86166f	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
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
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
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
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-7503-32	BREYNA	1 in 1 CARTON	AEROSOL, METERED	1		5
0378-7503-32	BREYNA	1 in 1 POUCH	AEROSOL, METERED	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-7503-32	GM - Gram	0378-7503	91831135-2bdc-4e02-a967-64ebfe5d1d35	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-7503	BREYNA (BUDESONIDE AND FORMOTEROL FUMARATE) AEROSOL, METERED [MYLAN PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250224_dc529fc4-bddb-4673-8202-dc401f86166f.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
BREYNA	BUDESONIDE AND FORMOTEROL FUMARATE	Mylan Pharmaceuticals Inc.	dc529fc4-bddb-4673-8202-dc401f86166f	2025-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211699 application number: ANDA211699 ndc (product): 0378-7503

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2597670	Breyna 160 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT	PSN	dc529fc4-bddb-4673-8202-dc401f86166f	5
2597673	Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT	PSN	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246304	budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246288	budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	dc529fc4-bddb-4673-8202-dc401f86166f	5
2597673	120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Breyna]	SBD	dc529fc4-bddb-4673-8202-dc401f86166f	5
2597670	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Breyna]	SBD	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246288	120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246304	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	dc529fc4-bddb-4673-8202-dc401f86166f	5
2597670	Breyna 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5
2597673	Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246288	budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246304	budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246304	budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5
1246288	budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	dc529fc4-bddb-4673-8202-dc401f86166f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0378-7503-32	00378750332	1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER	1 pouch	2023-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BREYNA - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-11-15	HUMAN PRESCRIPTION DRUG LABEL	5