FDA.reportPublic FDA data

Febuxostat

Product NDC
72205-028
11-digit product format
722050028
Labeler code
72205
Product ID
72205-028_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
40 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
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
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
72205-028-05Febuxostat500 in 1 BOTTLETABLET, FILM COATED5006
72205-028-30Febuxostat30 in 1 BOTTLETABLET, FILM COATED306
72205-028-90Febuxostat90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-028-30EA - Each72205-028da87cc31-ac9d-4d0c-a1c4-82756be89c0312020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-028FEBUXOSTAT TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 3 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
834235febuxostat 40 MG Oral TabletPSNa745be75-4fa5-cbf9-e053-2995a90a3a813
834235febuxostat 40 MG Oral TabletSCDa745be75-4fa5-cbf9-e053-2995a90a3a813
834235febuxostat 40 MG Oral TabletPSNbf4d29c8-4731-42bc-887a-d8302add9ca91
834235febuxostat 40 MG Oral TabletSCDbf4d29c8-4731-42bc-887a-d8302add9ca91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-028-0572205002805500 TABLET, FILM COATED in 1 BOTTLE (72205-028-05) 2019-12-300000-00-00NoNoCurrent
72205-028-307220500283030 TABLET, FILM COATED in 1 BOTTLE (72205-028-30) 2019-12-300000-00-00NoNoCurrent
72205-028-907220500289090 TABLET, FILM COATED in 1 BOTTLE (72205-028-90) 2019-12-300000-00-00NoNoCurrent