FDA.reportPublic FDA data

Febuxostat

Product NDC
33342-274
11-digit product format
333420274
Labeler code
33342
Product ID
33342-274_eb38172a-f884-4a94-be6d-73ad338fb29c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat tablets 40 mg
Dosage form
FILM
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207293
Marketing category
ANDA
Marketing start
2019-04-04
Substance
FEBUXOSTAT
Active strength
40 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
Febuxostat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii101V0R1N2E
Rxcui834235, 834241

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
33342-274-07Febuxostat30 in 1 BOTTLEFILM302
33342-274-10Febuxostat90 in 1 BOTTLEFILM902
33342-274-15Febuxostat500 in 1 BOTTLEFILM5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-274-07EA - Each33342-274262ee635-f3b8-4bbd-bff5-8451b96c5b1a12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-274FEBUXOSTAT (FEBUXOSTAT TABLETS 40 MG) FILM FEBUXOSTAT (FEBUXOSTAT TABLETS 80 MG) FILM [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 3 package rows20231012_77875ed1-049e-421b-a8d5-569b4af4a1b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN77875ed1-049e-421b-a8d5-569b4af4a1b52
834241febuxostat 80 MG Oral TabletPSN77875ed1-049e-421b-a8d5-569b4af4a1b52
834235febuxostat 40 MG Oral TabletSCD77875ed1-049e-421b-a8d5-569b4af4a1b52
834241febuxostat 80 MG Oral TabletSCD77875ed1-049e-421b-a8d5-569b4af4a1b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-274-073334202740730 FILM in 1 BOTTLE (33342-274-07) 30 film2019-04-04NoNoHistorical
33342-274-103334202741090 FILM in 1 BOTTLE (33342-274-10) 90 film2019-04-04NoNoHistorical
33342-274-1533342027415500 FILM in 1 BOTTLE (33342-274-15) 500 film2019-04-04NoNoHistorical