Budesonide

Product NDC: 0591-2510
11-digit product format: 005912510
Labeler code: 0591
Product ID: 0591-2510_dd750ef5-8e96-4f79-990e-59f99ffc3af4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA205457
Marketing category: ANDA
Marketing start: 2018-07-05
Substance: BUDESONIDE
Active strength: 9 mg/1
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 44.

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
A205457-001	BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205457-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205457-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-03	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A205457-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205457-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205457-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205457-001	AB	1	`a50c72e98297…`

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: Budesonide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	9 mg/1

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
0591-2510-30	Budesonide	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2510-30	EA - Each	0591-2510	ba0c93b2-da68-476a-833c-6cca331f30dc	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2510	BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	19	Current NDC, Legacy NDC, 1 package rows	20240823_41d4fd39-81ee-41be-b34d-efb12b3a359d.zip

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
1366550	budesonide 9 MG 24HR Extended Release Oral Tablet	PSN	41d4fd39-81ee-41be-b34d-efb12b3a359d	21
1366550	24 HR budesonide 9 MG Extended Release Oral Tablet	SCD	41d4fd39-81ee-41be-b34d-efb12b3a359d	21
1366550	budesonide 9 MG 24 HR Extended Release Oral Tablet	SY	41d4fd39-81ee-41be-b34d-efb12b3a359d	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2510-30	00591251030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)	2018-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	Golden State Medical Supply, Inc.	2025-08-12	HUMAN PRESCRIPTION DRUG LABEL	4
Budesonide	Actavis Pharma, Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	21
Budesonide	Golden State Medical Supply	2020-08-06	HUMAN PRESCRIPTION DRUG LABEL	2