FDA.reportPublic FDA data

Febuxostat

Product NDC
72205-029
11-digit product format
722050029
Labeler code
72205
Product ID
72205-029_acca11ed-dee8-41ea-bbfb-665392250dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Febuxostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA210461
Marketing category
ANDA
Marketing start
2019-12-30
Substance
FEBUXOSTAT
Active strength
80 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Febuxostat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEBUXOSTAT80 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
72205-029-30Febuxostat30 in 1 BOTTLETABLET, FILM COATED306
72205-029-90Febuxostat90 in 1 BOTTLETABLET, FILM COATED906
72205-029-91Febuxostat100 in 1 BOTTLETABLET, FILM COATED1006
72205-029-99Febuxostat1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-029-30EA - Each72205-0298ee236c2-8967-4494-9734-614931dccecc12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-029FEBUXOSTAT TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 4 package rows20240612_d1969ea8-5178-42ee-97fc-feee8595e677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSNd1969ea8-5178-42ee-97fc-feee8595e6776
834241febuxostat 80 MG Oral TabletPSNd1969ea8-5178-42ee-97fc-feee8595e6776
834235febuxostat 40 MG Oral TabletSCDd1969ea8-5178-42ee-97fc-feee8595e6776
834241febuxostat 80 MG Oral TabletSCDd1969ea8-5178-42ee-97fc-feee8595e6776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-029-307220500293030 TABLET, FILM COATED in 1 BOTTLE (72205-029-30) 2019-12-300000-00-00NoNoCurrent
72205-029-907220500299090 TABLET, FILM COATED in 1 BOTTLE (72205-029-90) 2026-02-20NoNoHistorical
72205-029-9172205002991100 TABLET, FILM COATED in 1 BOTTLE (72205-029-91) 2019-12-300000-00-00NoNoCurrent
72205-029-99722050029991000 TABLET, FILM COATED in 1 BOTTLE (72205-029-99) 2019-12-300000-00-00NoNoCurrent