Febuxostat

Product NDC: 0378-3926
11-digit product format: 003783926
Labeler code: 0378
Product ID: 0378-3926_3f5600cd-1f2f-410a-8c55-b8363d4fc492
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: febuxostat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA205385
Marketing category: ANDA
Marketing start: 2019-07-01
Marketing end: 0000-00-00
Substance: FEBUXOSTAT
Active strength: 80 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-3926		D	Discontinued by firm	2026-10-20
excluded package	package	0378-3926	0378-3926-05	D	Discontinued by firm	2026-10-20
excluded package	package	0378-3926	0378-3926-77	D	Discontinued by firm	2026-10-20
excluded package	package	0378-3926	0378-3926-93	D	Discontinued by firm	2026-10-20

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 · 48 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	0378-3926-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-3926-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-3926-05	`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	0378-3926-77	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-3926-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-3926-05	`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	0378-3926-77	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-3926-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-3926-05	`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	0378-3926-77	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-3926-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-3926-05	`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	0378-3926-77	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-3926-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-3926-05	`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	0378-3926-77	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-3926-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-3926-05	`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	0378-3926-77	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-3926-93	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-3926-05	`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	0378-3926-77	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-3926-93	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-3926-05	`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	0378-3926-77	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-3926-93	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-3926-05	`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	0378-3926-77	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-3926-93	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-3926-05	`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	0378-3926-77	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-3926-93	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-3926-05	`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	0378-3926-77	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-3926-93	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-3926-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205385-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL			2019-07-01
A205385-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL			2019-07-01

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 · 88 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
2026-10-15 13:18:30	2026-09	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL		2019-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL		2019-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205385-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205385-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-07-01	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205385-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205385-002	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	A205385-001	PC	2019-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205385-002	PC	2019-12-28	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205385-001	PC	2019-12-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205385-002	PC	2019-12-28	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3926-93	EA - Each	0378-3926	1c5931e5-bb42-4f6d-b260-2d19e1eade1e	1	2019-08-06

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3926-93	00378392693	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3926-93)	2019-07-01	0000-00-00	No	No	Current