ULORIC

Product NDC
43353-305
11-digit product format
433530305
Labeler code
43353
Product ID
43353-305_196bf4ca-b625-424a-8c4f-6be167d2bd2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021856
Marketing category
NDA
Marketing start
2009-02-13
Marketing end
0000-00-00
Substance
FEBUXOSTAT
Active strength
40 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-305-60ULORIC90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-305-60EA - Each43353-3051ad92a20-f01c-47b0-b614-6bd095d5905d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-305ULORIC (FEBUXOSTAT) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 1 package rows20191219_24ac0ee2-cd7b-4dda-a1bb-271e32331758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN24ac0ee2-cd7b-4dda-a1bb-271e323317583
834239Uloric 40 MG Oral TabletPSN24ac0ee2-cd7b-4dda-a1bb-271e323317583
834239febuxostat 40 MG Oral Tablet [Uloric]SBD24ac0ee2-cd7b-4dda-a1bb-271e323317583
834235febuxostat 40 MG Oral TabletSCD24ac0ee2-cd7b-4dda-a1bb-271e323317583
834239Uloric 40 MG Oral TabletSY24ac0ee2-cd7b-4dda-a1bb-271e323317583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-305-604335303056090 TABLET in 1 BOTTLE (43353-305-60) 90 tablet2017-04-070000-00-00NoNoCurrent