FDA.reportPublic FDA data

Febuxostat

Product NDC
0904-7485
Requested package NDC
0904-7485-03
11-digit product format
009047485
Labeler code
0904
Product ID
0904-7485_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
2026-08-31
Substance
FEBUXOSTAT
Active strength
80 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210461-001FEBUXOSTATFEBUXOSTAT40MGTABLET / ORALAB2019-12-30
A210461-002FEBUXOSTATFEBUXOSTAT80MGTABLET / ORALAB2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210461-001AB
A210461-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210461-001FEBUXOSTAT40MGTABLET / ORALAB2019-12-30a50c72e98297…
2026-08-01 22:54:322026-06A210461-002FEBUXOSTAT80MGTABLET / ORALAB2019-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210461-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210461-002AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FebuxostatFEBUXOSTATNovadoz Pharmaceuticals LLCd1969ea8-5178-42ee-97fc-feee8595e6772026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210461
application number: ANDA210461
FebuxostatFEBUXOSTATMajor Pharmaceuticals164feabd-f722-445b-b81a-d975b3db5f532025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210461
application number: ANDA210461
ndc (package): 0904-7485-03
ndc (product): 0904-7485
ndc11 (package): 00904748503
FebuxostatFEBUXOSTATNuCare Pharmaceuticals,Inc.a745be75-4fa5-cbf9-e053-2995a90a3a812024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210461
application number: ANDA210461
FebuxostatFEBUXOSTATMAJOR PHARMACEUTICALS13a80059-46f7-4453-ab37-72744657a08a2024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210461
application number: ANDA210461
FebuxostatFEBUXOSTATAphena Pharma Solutions - Tennessee, LLCbf4d29c8-4731-42bc-887a-d8302add9ca92020-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210461
application number: ANDA210461

Additional Listing Data#

Finished product
Yes
Brand name base
Febuxostat

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101V0R1N2EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
164feabd-f722-445b-b81a-d975b3db5f53Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
253cf2a8-e060-f2e5-7334-8565436b95e4Product name620240213
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7485-03Febuxostat30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7485-03EA - Each0904-7485d59daed1-5488-49e2-8209-9df743a8479912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7485FEBUXOSTAT TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2Current NDC, 1 package rows20240927_164feabd-f722-445b-b81a-d975b3db5f53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN164feabd-f722-445b-b81a-d975b3db5f534
834241febuxostat 80 MG Oral TabletPSN164feabd-f722-445b-b81a-d975b3db5f534
834235febuxostat 40 MG Oral TabletSCD164feabd-f722-445b-b81a-d975b3db5f534
834241febuxostat 80 MG Oral TabletSCD164feabd-f722-445b-b81a-d975b3db5f534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7485-030090474850330 TABLET, FILM COATED in 1 BOTTLE (0904-7485-03) 2024-05-222026-08-31NoNoHistorical