Entocort EC

Product NDC: 0574-9850
Requested package NDC: 0574-9850-10
11-digit product format: 005749850
Labeler code: 0574
Product ID: 0574-9850_8d53681c-2c90-4406-8229-2fbd78ecf5d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: CAPSULE
Route: ORAL
Labeler: Padagis US LLC
Application: NDA021324
Marketing category: NDA
Marketing start: 2001-10-29
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 3 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0574-9850	0574-9850-10	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
N021324-001	ENTOCORT EC	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021324-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	ENTOCORT EC	3MG	CAPSULE / ORAL	AB	RLD, RS	2001-10-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021324-001	ENTOCORT EC	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2001-10-02	`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	N021324-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021324-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021324-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021324-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021324-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021324-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021324-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021324-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021324-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021324-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021324-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021324-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021324-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021324-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021324-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021324-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021324-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021324-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021324-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021324-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021324-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021324-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021324-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021324-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021324-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021324-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021324-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021324-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021324-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021324-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021324-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021324-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021324-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021324-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021324-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021324-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021324-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021324-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021324-001	M-178	2019-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021324-001	NPP	2019-04-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021324-001	M-178	2019-04-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021324-001	NPP	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021324-001	M-178	2019-04-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021324-001	NPP	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021324-001	M-178	2019-04-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021324-001	NPP	2019-04-29	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-9850-10	EA - Each	0574-9850	b40e7e19-ce98-4939-9ea0-1afc9391c2ff	1	2016-11-08

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide	BUDESONIDE	Bryant Ranch Prepack	33def4dc-b469-f987-e063-6294a90ace0b	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324
budesonide	BUDESONIDE	Golden State Medical Supply, Inc.	263303c2-8e4f-7b6c-e063-6394a90aef9e	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324
budesonide	BUDESONIDE	Padagis US LLC	3a18d5a7-04c5-4137-8155-70a8adc0a48b	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021324 application number: NDA021324

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-9850-10	00574985010	100 CAPSULE in 1 BOTTLE (0574-9850-10)	100 capsule	2001-10-29	0000-00-00	No	No	Current