Budesonide

Product NDC: 0378-4500
11-digit product format: 003784500
Labeler code: 0378
Product ID: 0378-4500_812acf8d-0936-4ba9-9952-ae9f2266649b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA208851
Marketing category: ANDA
Marketing start: 2020-10-21
Substance: BUDESONIDE
Active strength: 9 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4500-93	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4500-93	`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
A208851-001	BUDESONIDE	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208851-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208851-001	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-09-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208851-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208851-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208851-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208851-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208851-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208851-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208851-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208851-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208851-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208851-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208851-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208851-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208851-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208851-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208851-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208851-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208851-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208851-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208851-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208851-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208851-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208851-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208851-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208851-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208851-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208851-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208851-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208851-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208851-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208851-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208851-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208851-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208851-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208851-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208851-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208851-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208851-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	9 mg/1

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
1366550	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
f7265276-e649-4bc4-8ac8-1f5ac2b984e8	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
0378-4500-93	Budesonide	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4500	BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250330_f7265276-e649-4bc4-8ac8-1f5ac2b984e8.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
Budesonide	BUDESONIDE	Mylan Pharmaceuticals Inc.	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208851 application number: ANDA208851 ndc (product): 0378-4500

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	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	8
1366550	24 HR budesonide 9 MG Extended Release Oral Tablet	SCD	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	8
1366550	budesonide 9 MG 24 HR Extended Release Oral Tablet	SY	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4500-93	00378450093	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93)	2020-10-21	2030-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	Golden State Medical Supply, Inc.	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	2
Budesonide	Mylan Pharmaceuticals Inc.	2024-11-15	HUMAN PRESCRIPTION DRUG LABEL	8