Febuxostat

Product NDC: 69539-035
11-digit product format: 695390035
Labeler code: 69539
Product ID: 69539-035_778b95e5-ced2-4b08-b0b6-baa7fd82e4ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Febuxostat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA210461
Marketing category: ANDA
Marketing start: 2019-12-30
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: 2023-12-31
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	69539-035		D	Discontinued by firm	2026-08-17
excluded package	package	69539-035	69539-035-05	D	Discontinued by firm	2026-08-17
excluded package	package	69539-035	69539-035-30	D	Discontinued by firm	2026-08-17
excluded package	package	69539-035	69539-035-90	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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	69539-035-05
excluded package	package	69539-035-90
excluded package	package	69539-035-30

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-035	FEBUXOSTAT TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]	5	Legacy NDC	20230811_b94994e0-cdb5-42cc-bc3c-75154e87561d.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-035-05	69539003505	500 TABLET, FILM COATED in 1 BOTTLE (69539-035-05)	2019-12-30	0000-00-00	No	No	Current
69539-035-30	69539003530	30 TABLET, FILM COATED in 1 BOTTLE (69539-035-30)	2019-12-30	0000-00-00	No	No	Current
69539-035-90	69539003590	90 TABLET, FILM COATED in 1 BOTTLE (69539-035-90)	2019-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Febuxostat	MSN LABORATORIES PRIVATE LIMITED \| MSN Pharmaceuticals Inc.	2023-07-26	Human Prescription Drug Label	5