Febuxostat

Product NDC: 0904-7396
11-digit product format: 009047396
Labeler code: 0904
Product ID: 0904-7396_2a8a681c-a419-43c5-b5ba-f6596aeb6677
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Febuxostat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MAJOR PHARMACEUTICALS
Application: ANDA210461
Marketing category: ANDA
Marketing start: 2019-12-30
Substance: FEBUXOSTAT
Active strength: 80 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A210461-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2019-12-30
A210461-002	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
A210461-001	AB
A210461-002	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	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	BX	2019-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	BX	2019-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210461-002	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	A210461-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210461-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210461-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210461-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210461-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210461-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210461-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210461-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210461-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210461-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210461-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210461-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210461-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210461-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210461-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210461-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210461-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210461-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210461-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210461-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210461-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210461-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210461-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210461-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210461-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210461-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210461-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210461-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210461-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210461-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210461-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210461-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210461-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210461-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210461-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210461-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210461-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210461-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210461-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210461-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Febuxostat
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEBUXOSTAT	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
101V0R1N2E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834235	Internal RxNorm lookup
834241	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
13a80059-46f7-4453-ab37-72744657a08a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
253cf2a8-e060-f2e5-7334-8565436b95e4	Product name	6	20240213
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7396-46	Febuxostat	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7396-46	EA - Each	0904-7396	817ec2fa-f4ed-466c-83b1-4ba30a638234	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7396	FEBUXOSTAT TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2	Current NDC, 1 package rows	20240702_13a80059-46f7-4453-ab37-72744657a08a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Febuxostat	FEBUXOSTAT	Novadoz Pharmaceuticals LLC	d1969ea8-5178-42ee-97fc-feee8595e677	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210461 application number: ANDA210461
Febuxostat	FEBUXOSTAT	Major Pharmaceuticals	164feabd-f722-445b-b81a-d975b3db5f53	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210461 application number: ANDA210461
Febuxostat	FEBUXOSTAT	NuCare Pharmaceuticals,Inc.	a745be75-4fa5-cbf9-e053-2995a90a3a81	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210461 application number: ANDA210461
Febuxostat	FEBUXOSTAT	MAJOR PHARMACEUTICALS	13a80059-46f7-4453-ab37-72744657a08a	2024-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210461 application number: ANDA210461 ndc (product): 0904-7396
Febuxostat	FEBUXOSTAT	Aphena Pharma Solutions - Tennessee, LLC	bf4d29c8-4731-42bc-887a-d8302add9ca9	2020-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210461 application number: ANDA210461

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	164feabd-f722-445b-b81a-d975b3db5f53	4
834241	febuxostat 80 MG Oral Tablet	PSN	164feabd-f722-445b-b81a-d975b3db5f53	4
834235	febuxostat 40 MG Oral Tablet	SCD	164feabd-f722-445b-b81a-d975b3db5f53	4
834241	febuxostat 80 MG Oral Tablet	SCD	164feabd-f722-445b-b81a-d975b3db5f53	4
834235	febuxostat 40 MG Oral Tablet	PSN	13a80059-46f7-4453-ab37-72744657a08a	2
834241	febuxostat 80 MG Oral Tablet	PSN	13a80059-46f7-4453-ab37-72744657a08a	2
834235	febuxostat 40 MG Oral Tablet	SCD	13a80059-46f7-4453-ab37-72744657a08a	2
834241	febuxostat 80 MG Oral Tablet	SCD	13a80059-46f7-4453-ab37-72744657a08a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0904-7396-46	00904739646	30 TABLET, FILM COATED in 1 BOTTLE (0904-7396-46)	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Febuxostat	Major Pharmaceuticals	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	4
Febuxostat	MAJOR PHARMACEUTICALS \| MSN Pharmaceuticals Inc.	2024-06-04	Human Prescription Drug Label	2