BUDESONIDE (ENTERIC COATED)

Product NDC: 51862-580
11-digit product format: 518620580
Labeler code: 51862
Product ID: 51862-580_d9a1678d-e215-4bed-a484-317d658fbe11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA206623
Marketing category: ANDA
Marketing start: 2019-10-31
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 3 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51862-580		D	Discontinued by firm		2026-08-03
excluded package	package	51862-580	51862-580-01	D	Discontinued by firm		2026-08-03

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
A206623-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2016-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206623-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206623-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2016-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206623-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-04-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206623-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206623-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206623-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206623-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206623-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206623-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206623-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206623-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206623-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206623-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206623-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206623-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206623-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206623-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206623-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206623-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206623-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206623-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206623-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206623-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206623-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206623-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206623-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206623-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206623-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206623-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206623-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206623-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206623-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206623-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206623-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206623-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206623-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206623-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206623-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206623-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206623-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206623-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206623-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206623-001	AB	1	`cb3db0bc1861…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-580-01	EA - Each	51862-580	9018b03f-3560-4c61-bd2c-d8525bd32a92	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-580	BUDESONIDE (ENTERIC COATED) (BUDESONIDE) CAPSULE, DELAYED RELEASE PELLETS [MAYNE PHARMA INC.]	2	Legacy NDC	20221213_0659420e-e376-4b90-98bf-71af41c18676.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-580-01	51862058001	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)	2019-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUDESONIDE (ENTERIC COATED)	Mayne Pharma Inc. \| Mayne Pharma International Pty Ltd \| Catalent Greenville, Inc.	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	3
BUDESONIDE (ENTERIC COATED)	Golden State Medical Supply, Inc.	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	4