Febuxostat

Product NDC: 0904-7484
Requested package NDC: 0904-7484-03
11-digit product format: 009047484
Labeler code: 0904
Product ID: 0904-7484_2bc97ac5-e672-4bb9-b0c4-596bbe935292
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Febuxostat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA210461
Marketing category: ANDA
Marketing start: 2024-05-22
Marketing end: 2026-07-31
Substance: FEBUXOSTAT
Active strength: 40 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0904-7484	0904-7484-03	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 74 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
2026-02-19 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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210461-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2019-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210461-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2019-12-30	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210461-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210461-002	AB	1	`87673890dc5c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 0904-7484-03 ndc (product): 0904-7484 ndc11 (package): 00904748403
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
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

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
0904-7484-03	Febuxostat	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7484-03	EA - Each	0904-7484	84b477d0-c416-471d-9794-d2a337d7b49d	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7484	FEBUXOSTAT TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2	Current NDC, 1 package rows	20240927_164feabd-f722-445b-b81a-d975b3db5f53.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7484-03	00904748403	30 TABLET, FILM COATED in 1 BOTTLE (0904-7484-03)	2024-05-22	2026-07-31	No	No	Historical