Febuxostat

Product NDC: 14445-157
11-digit product format: 144450157
Labeler code: 14445
Product ID: 14445-157_60d6e78a-98f8-4968-ad5f-37689cc2c096
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Febuxostat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Indoco Remedies Limited
Application: ANDA210292
Marketing category: ANDA
Marketing start: 2017-02-15
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: 2021-12-31
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	14445-157		I	Inactivated by FDA	2026-08-17
excluded package	package	14445-157	14445-157-00	I	Inactivated by FDA	2026-08-17
excluded package	package	14445-157	14445-157-01	I	Inactivated by FDA	2026-08-17
excluded package	package	14445-157	14445-157-30	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	14445-157-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	14445-157-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	14445-157-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	14445-157-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	14445-157-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	14445-157-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	14445-157-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	14445-157-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	14445-157-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	14445-157-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	14445-157-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	14445-157-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	14445-157-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	14445-157-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	14445-157-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	14445-157-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	14445-157-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	14445-157-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	14445-157-00	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	14445-157-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	14445-157-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	14445-157-00	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	14445-157-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	14445-157-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	14445-157-00	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	14445-157-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	14445-157-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
14445-157-00	2025-01-30	C162847	48780-1	2cef2736-60a0-d83d-e063-dadaa90ab31f	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
14445-157-01	2025-01-30	C162847	48780-1	2cef2736-60a0-d83d-e063-dadaa90ab31f	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
14445-157-30	2025-01-30	C162847	48780-1	2cef2736-60a0-d83d-e063-dadaa90ab31f	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	SPL version
14445-157-00	Febuxostat	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	7
14445-157-01	Febuxostat	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
14445-157-30	Febuxostat	30 in 1 BOTTLE	TABLET, FILM COATED	30	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14445-157	FEBUXOSTAT TABLET, FILM COATED [INDOCO REMEDIES LIMITED ]	7	Legacy NDC, 3 package rows	20200113_39ee3ba8-af0d-4273-8c2e-552ba19084a4.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	39ee3ba8-af0d-4273-8c2e-552ba19084a4	7
834241	febuxostat 80 MG Oral Tablet	PSN	39ee3ba8-af0d-4273-8c2e-552ba19084a4	7
834235	febuxostat 40 MG Oral Tablet	SCD	39ee3ba8-af0d-4273-8c2e-552ba19084a4	7
834241	febuxostat 80 MG Oral Tablet	SCD	39ee3ba8-af0d-4273-8c2e-552ba19084a4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
14445-157-00	14445015700	1000 TABLET, FILM COATED in 1 BOTTLE (14445-157-00)	2017-02-15	0000-00-00	No	No	Current
14445-157-01	14445015701	100 TABLET, FILM COATED in 1 BOTTLE (14445-157-01)	2017-02-15	0000-00-00	No	No	Current
14445-157-30	14445015730	30 TABLET, FILM COATED in 1 BOTTLE (14445-157-30)	2017-02-15	0000-00-00	No	No	Current