ULORIC

Product NDC: 55154-5159
11-digit product format: 551545159
Labeler code: 55154
Product ID: 55154-5159_3d9127b7-1357-46b2-8782-9d84130b92b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: febuxostat
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health
Application: NDA021856
Marketing category: NDA
Marketing start: 2009-02-13
Marketing end: 2023-08-31
Substance: FEBUXOSTAT
Active strength: 80 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55154-5159		D	Discontinued by firm		2026-08-17
excluded package	package	55154-5159	55154-5159-8	D	Discontinued by firm		2026-08-17

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-5159-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-5159-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-5159-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-5159-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-5159-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-5159-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-5159-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-5159-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-5159-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-5159-8	`ad56d346431e…`	`cc804d4bbf1e…`
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	55154-5159-8	`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	55154-5159-8	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021856-001	ULORIC	FEBUXOSTAT	40MG	TABLET / ORAL	AB	RLD	2009-02-13
N021856-002	ULORIC	FEBUXOSTAT	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021856-001	AB
N021856-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021856-001	8372872	2031-09-08	U-1346	2013-02-26
N021856-001	9107912	2031-09-08	U-1346	2015-09-03
N021856-002	8372872	2031-09-08	U-1346
N021856-002	9107912	2031-09-08	U-1346	2015-09-03

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021856-001	ULORIC	40MG	TABLET / ORAL	AB	RLD	2009-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021856-002	ULORIC	80MG	TABLET / ORAL	AB	RLD, RS	2009-02-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021856-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021856-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021856-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 254 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021856-002	8372872	2031-09-08	U-1346			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021856-002	8372872	2031-09-08	U-1346			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-002	8372872	2031-09-08	U-1346			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021856-002	8372872	2031-09-08	U-1346			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-002	8372872	2031-09-08	U-1346			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-002	8372872	2031-09-08	U-1346			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-001	7361676	2024-03-08		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-002	7361676	2024-03-08		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-002	8372872	2031-09-08	U-1346			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-001	7361676	2024-03-08		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-002	7361676	2024-03-08		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-002	8372872	2031-09-08	U-1346			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021856-002	9107912	2031-09-08	U-1346		2015-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-001	7361676	2024-03-08		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-001	8372872	2031-09-08	U-1346		2013-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-001	9107912	2031-09-08	U-1346		2015-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021856-002	7361676	2024-03-08		Drug product		`5bbf6a4d5a75…`

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	N021856-001	M-205	2020-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021856-002	M-205	2020-08-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021856-001	M-205	2020-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021856-002	M-205	2020-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021856-001	M-205	2020-08-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021856-002	M-205	2020-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021856-001	M-205	2020-08-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021856-002	M-205	2020-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021856-001	M-205	2020-08-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021856-002	M-205	2020-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021856-001	M-205	2020-08-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021856-002	M-205	2020-08-15	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
febuxostat	ACTIVE INGREDIENT	101V0R1N2E	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
febuxostat	ACTIVE MOIETY	101V0R1N2E	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH]	3

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
ULORIC	FEBUXOSTAT	Takeda Pharmaceuticals America, Inc.	54de10ef-fe5f-4930-b91d-6bbb04c664bd	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021856 application number: NDA021856

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
101V0R1N2E	FEBUXOSTAT	144060-53-7	FEBUXOSTAT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-5159-8	55154515908	900 TABLET in 1 BOTTLE, PLASTIC (55154-5159-8)	900 tablet	2009-02-13	2023-08-31	No	No	Current