Budesonide

Product NDC: 55154-4849
11-digit product format: 551544849
Labeler code: 55154
Product ID: 55154-4849_7f50d9f4-6e77-40cc-8701-63f8aaaa0d98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: Cardinal Health 107, LLC
Application: ANDA077519
Marketing category: ANDA
Marketing start: 2019-01-11
Substance: BUDESONIDE
Active strength: .5 mg/2mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
A077519-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN		2008-11-18
A077519-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2008-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077519-001	AN
A077519-002	AN

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077519-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077519-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2008-11-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077519-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077519-002	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077519-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077519-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077519-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077519-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077519-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077519-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077519-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077519-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077519-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077519-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077519-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077519-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077519-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077519-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077519-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077519-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077519-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077519-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077519-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077519-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077519-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077519-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077519-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077519-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077519-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077519-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077519-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077519-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077519-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077519-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077519-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077519-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077519-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077519-002	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077519-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077519-002	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077519-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077519-002	AN	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	.5 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351109	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
3e8a6cf4-4bda-4e22-8653-12635adfb316	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
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
55154-4849-5	Budesonide	5 in 1 BAG	SUSPENSION	5		7
55154-4849-5	Budesonide	2 mL in 1 VIAL, SINGLE-DOSE	SUSPENSION	2		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-4849	BUDESONIDE SUSPENSION [CARDINAL HEALTH 107, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240430_3e8a6cf4-4bda-4e22-8653-12635adfb316.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Cardinal Health 107, LLC	3e8a6cf4-4bda-4e22-8653-12635adfb316	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077519 application number: ANDA077519 ndc (product): 55154-4849
Budesonide	BUDESONIDE	A-S Medication Solutions	32e30f11-e19b-4e23-a893-92d95e48edef	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077519 application number: ANDA077519
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	4f126a29-38f7-4c4c-8978-37e72b289902	2021-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077519 application number: ANDA077519
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	2414058b-5d39-42f2-915f-03a5e1101ab5	2021-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077519 application number: ANDA077519

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351109	budesonide 0.5 MG in 2 ML Inhalation Suspension	PSN	3e8a6cf4-4bda-4e22-8653-12635adfb316	7
351109	budesonide 0.25 MG/ML Inhalation Suspension	SCD	3e8a6cf4-4bda-4e22-8653-12635adfb316	7
351109	budesonide 0.5 MG per 2 ML Inhalation Suspension	SY	3e8a6cf4-4bda-4e22-8653-12635adfb316	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-4849-5	55154484905	5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5) / 2 mL in 1 VIAL, SINGLE-DOSE	2019-01-11	0000-00-00	No	No	Current