Febuxostat Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 21:10:55

Label at a glance#

Productfebuxostat

Active ingredientFEBUXOSTAT

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Febuxostat Tablets, 40 mg – 30's count

NDC- 70771-1552-3

Febuxostat Tablets, 80 mg – 30's count

NDC- 70771-1553-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
834235	febuxostat 40 MG Oral Tablet	PSN	3
834241	febuxostat 80 MG Oral Tablet	PSN	3
834235	febuxostat 40 MG Oral Tablet	SCD	3
834241	febuxostat 80 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEBUXOSTAT Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
253cf2a8-e060-f2e5-7334-8565436b95e4	Product name	6	20240213
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1552-0	febuxostat	1000 in 1 BOTTLE	TABLET	1000	3
70771-1552-1	febuxostat	100 in 1 BOTTLE	TABLET	100	3
70771-1552-3	febuxostat	30 in 1 BOTTLE	TABLET	30	3
70771-1552-4	febuxostat	10 in 1 BLISTER PACK	TABLET	10	3
70771-1552-4	febuxostat	10 in 1 CARTON	TABLET	10	3
70771-1552-5	febuxostat	500 in 1 BOTTLE	TABLET	500	3
70771-1552-9	febuxostat	90 in 1 BOTTLE	TABLET	90	3
70771-1553-0	febuxostat	1000 in 1 BOTTLE	TABLET	1000	3
70771-1553-1	febuxostat	100 in 1 BOTTLE	TABLET	100	3
70771-1553-3	febuxostat	30 in 1 BOTTLE	TABLET	30	3
70771-1553-4	febuxostat	10 in 1 BLISTER PACK	TABLET	10	3
70771-1553-4	febuxostat	10 in 1 CARTON	TABLET	10	3
70771-1553-5	febuxostat	500 in 1 BOTTLE	TABLET	500	3
70771-1553-9	febuxostat	90 in 1 BOTTLE	TABLET	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1552	FEBUXOSTAT TABLET [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, 7 package rows	20240821_0629ab39-196e-4198-902a-3c16277ba205.zip
70771-1553	FEBUXOSTAT TABLET [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, 7 package rows	20240821_0629ab39-196e-4198-902a-3c16277ba205.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

febuxostat
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1552	70771-1552-3, 70771-1552-9, 70771-1552-1, 70771-1552-5, 70771-1552-0, 70771-1552-4
70771-1553	70771-1553-3, 70771-1553-9, 70771-1553-1, 70771-1553-5, 70771-1553-0, 70771-1553-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEBUXOSTAT	101V0R1N2E	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FEBUXOSTAT	101V0R1N2E	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205443-001	FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET / ORAL	AB		2023-01-09
A205443-002	FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET / ORAL	AB		2023-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205443-001	AB
A205443-002	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 · 54 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
2026-10-15 13:18:30	2026-09	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205443-001	FEBUXOSTAT	40MG	TABLET / ORAL	AB	2023-01-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205443-002	FEBUXOSTAT	80MG	TABLET / ORAL	AB	2023-01-09	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A205443-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205443-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205443-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205443-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205443-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205443-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205443-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205443-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205443-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205443-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205443-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205443-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205443-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205443-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205443-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205443-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205443-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205443-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205443-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205443-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205443-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205443-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205443-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205443-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205443-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205443-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205443-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205443-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205443-002	AB	1	`ea1830bbd6c7…`

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	Zydus Lifesciences Limited	0629ab39-196e-4198-902a-3c16277ba205	2024-08-16		Exact identifier ndc (package): 70771-1552-5 ndc (package): 70771-1552-3 ndc (package): 70771-1553-5 ndc (package): 70771-1553-4 ndc (package): 70771-1553-3 ndc (package): 70771-1552-1 ndc (package): 70771-1553-1 ndc (package): 70771-1552-9 ndc (package): 70771-1553-9 ndc (package): 70771-1552-4 ndc (package): 70771-1552-0 ndc (package): 70771-1553-0 ndc (product): 70771-1553 ndc (product): 70771-1552 ndc11 (package): 70771155201 ndc11 (package): 70771155301 ndc11 (package): 70771155203 ndc11 (package): 70771155303 ndc11 (package): 70771155300 ndc11 (package): 70771155200 ndc11 (package): 70771155209 ndc11 (package): 70771155305 ndc11 (package): 70771155205 ndc11 (package): 70771155309 ndc11 (package): 70771155204 ndc11 (package): 70771155304 spl id: 2a9fa82f-de69-4251-8560-5a59d41356b7 spl set id: 0629ab39-196e-4198-902a-3c16277ba205

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.