Febuxostat

Product NDC: 71610-585
Requested package NDC: 71610-585-60
11-digit product format: 716100585
Labeler code: 71610
Product ID: 71610-585_2f9f373e-d40d-4163-90a9-f53b7eb24cd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: febuxostat
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA210292
Marketing category: ANDA
Marketing start: 2020-09-28
Marketing end: 0000-00-00
Substance: FEBUXOSTAT
Active strength: 40 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [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	71610-585	71610-585-60	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A210292-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2019-12-30
A210292-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL	AB		2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210292-001	AB
A210292-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210292-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210292-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A210292-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210292-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210292-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210292-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210292-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210292-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210292-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210292-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210292-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210292-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210292-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210292-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210292-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210292-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210292-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210292-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210292-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210292-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210292-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210292-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210292-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210292-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210292-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210292-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210292-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210292-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210292-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210292-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210292-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210292-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210292-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210292-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210292-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210292-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210292-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210292-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210292-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210292-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210292-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210292-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
253cf2a8-e060-f2e5-7334-8565436b95e4	Product name	6	20240213

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-585-60	2023-01-30	C162847	48780-1	f386c649-feb7-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FEBUXOSTAT TABLETS safely and effectively. See full prescribing information for FEBUXOSTAT TABLETS. FEBUXOSTAT tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-585-60	Febuxostat	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-585-60	EA - Each	71610-585	9b64c26e-0779-4bf6-99bf-3734984c45d0	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-585	FEBUXOSTAT TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20210811_8ed19d23-b91c-4e5a-b1c5-24e355b8c0a4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Febuxostat	FEBUXOSTAT	Tris Pharma Inc	d3b18653-9487-4a78-82c0-80ee024b8ef6	2023-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210292 application number: ANDA210292

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834235	febuxostat 40 MG Oral Tablet	PSN	8ed19d23-b91c-4e5a-b1c5-24e355b8c0a4	1
834235	febuxostat 40 MG Oral Tablet	SCD	8ed19d23-b91c-4e5a-b1c5-24e355b8c0a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-585-60	71610058560	90 TABLET in 1 BOTTLE (71610-585-60)	90 tablet	2021-07-26	0000-00-00	No	No	Current