ENTOCORT

Product NDC: 65483-702
11-digit product format: 654830702
Labeler code: 65483
Product ID: 65483-702_c99a57a5-655a-4ded-9397-eb7881a3e670
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: CAPSULE
Route: ORAL
Labeler: Prometheus Laboratories Inc
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: E
Listing certified through: 2017-12-31
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	65483-702		D	Discontinued by firm		2026-08-03
excluded package	package	65483-702	65483-702-10	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65483-702-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65483-702-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65483-702-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65483-702-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65483-702-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65483-702-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65483-702-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65483-702-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65483-702-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65483-702-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65483-702-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65483-702-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65483-702-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65483-702-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65483-702-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65483-702-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65483-702-10	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65483-702-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-702-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65483-702-10	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65483-702-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65483-702-10	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65483-702-10	2025-08-15	C162847	48780-1	97449f38-b89d-f6ea-e053-dbdaa90aa703	ENTOCORT® EC (budesonide) CAPSULES
65483-702-10	2019-11-13	C162847	48780-1	97449f38-b89d-f6ea-e053-dbdaa90aa703	ENTOCORT® EC (budesonide) CAPSULES

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65483-702-10	EA - Each	65483-702	61e51af3-1570-42f3-b0f8-f6f897a81ed2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65483-702	ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]	6	Legacy NDC	20120125_fe6530ef-1b23-451f-1290-0e3ef02ec1b5.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1244214	budesonide 3 MG Delayed Release Oral Capsule	PSN	98a4eca1-904c-4355-957a-b5a141573cc2	2
1244215	Entocort EC 3 MG Delayed Release Oral Capsule	PSN	98a4eca1-904c-4355-957a-b5a141573cc2	2
1244215	budesonide 3 MG Delayed Release Oral Capsule [Entocort]	SBD	98a4eca1-904c-4355-957a-b5a141573cc2	2
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	98a4eca1-904c-4355-957a-b5a141573cc2	2
1244215	Entocort EC 3 MG Delayed Release Oral Capsule	SY	98a4eca1-904c-4355-957a-b5a141573cc2	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENTOCORT® EC (budesonide) CAPSULES	Physicians Total Care, Inc.	2012-02-07	HUMAN PRESCRIPTION DRUG LABEL	2
ENTOCORT® EC (budesonide) CAPSULES	Prometheus Laboratories Inc \| AstraZeneca PLC \| AstraZeneca AB	2009-06-24	HUMAN PRESCRIPTION DRUG LABEL	6