FDA.reportPublic FDA data

ULORIC

Product NDC
64764-677
11-digit product format
647640677
Labeler code
64764
Product ID
64764-677_16c36a5a-2f72-4df7-aa6f-1ca27a39404f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021856
Marketing category
NDA
Marketing start
2009-02-13
Substance
FEBUXOSTAT
Active strength
80 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ULORIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii101V0R1N2E
Rxcui834235, 834239, 834241, 834243

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
253cf2a8-e060-f2e5-7334-8565436b95e4Product name620240213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-677-11ULORIC10 in 1 BLISTER PACKTABLET1017
64764-677-11ULORIC10 in 1 CARTONTABLET1017
64764-677-13ULORIC100 in 1 BOTTLETABLET10017
64764-677-19ULORIC1000 in 1 BOTTLETABLET100017
64764-677-30ULORIC30 in 1 BOTTLETABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-677-30EA - Each64764-6775ef07aa1-2727-40d8-b157-562446819f7512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
febuxostatACTIVE INGREDIENT101V0R1N2EULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
febuxostatACTIVE MOIETY101V0R1N2EULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]8
febuxostatACTIVE INGREDIENT101V0R1N2EULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
febuxostatACTIVE MOIETY101V0R1N2EULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-677ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]16Current NDC, Legacy NDC, 5 package rows20230502_54de10ef-fe5f-4930-b91d-6bbb04c664bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834241febuxostat 80 MG Oral TabletPSN54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834239Uloric 40 MG Oral TabletPSN54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834243Uloric 80 MG Oral TabletPSN54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834239febuxostat 40 MG Oral Tablet [Uloric]SBD54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834243febuxostat 80 MG Oral Tablet [Uloric]SBD54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834235febuxostat 40 MG Oral TabletSCD54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834241febuxostat 80 MG Oral TabletSCD54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834239Uloric 40 MG Oral TabletSY54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834243Uloric 80 MG Oral TabletSY54de10ef-fe5f-4930-b91d-6bbb04c664bd17
834241febuxostat 80 MG Oral TabletPSNae1e0d8a-03fc-419b-9d44-afa68fbd56811
834243Uloric 80 MG Oral TabletPSNae1e0d8a-03fc-419b-9d44-afa68fbd56811
834243febuxostat 80 MG Oral Tablet [Uloric]SBDae1e0d8a-03fc-419b-9d44-afa68fbd56811
834241febuxostat 80 MG Oral TabletSCDae1e0d8a-03fc-419b-9d44-afa68fbd56811
834243Uloric 80 MG Oral TabletSYae1e0d8a-03fc-419b-9d44-afa68fbd56811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-677-116476406771110 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK10 blister pack2009-02-130000-00-00NoNoCurrent
64764-677-1364764067713100 TABLET in 1 BOTTLE (64764-677-13) 100 tablet2009-02-130000-00-00NoNoCurrent
64764-677-19647640677191000 TABLET in 1 BOTTLE (64764-677-19) 1000 tablet2009-02-130000-00-00NoNoCurrent
64764-677-306476406773030 TABLET in 1 BOTTLE (64764-677-30) 30 tablet2009-02-130000-00-00NoNoCurrent