FDA.reportPublic FDA data

febuxostat

Product NDC
70771-1552
11-digit product format
707711552
Labeler code
70771
Product ID
70771-1552_2a9fa82f-de69-4251-8560-5a59d41356b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205443
Marketing category
ANDA
Marketing start
2023-03-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1552-0febuxostat1000 in 1 BOTTLETABLET10003
70771-1552-1febuxostat100 in 1 BOTTLETABLET1003
70771-1552-3febuxostat30 in 1 BOTTLETABLET303
70771-1552-4febuxostat10 in 1 BLISTER PACKTABLET103
70771-1552-4febuxostat10 in 1 CARTONTABLET103
70771-1552-5febuxostat500 in 1 BOTTLETABLET5003
70771-1552-9febuxostat90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1552FEBUXOSTAT TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 7 package rows20240821_0629ab39-196e-4198-902a-3c16277ba205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834235febuxostat 40 MG Oral TabletPSN0629ab39-196e-4198-902a-3c16277ba2053
834241febuxostat 80 MG Oral TabletPSN0629ab39-196e-4198-902a-3c16277ba2053
834235febuxostat 40 MG Oral TabletSCD0629ab39-196e-4198-902a-3c16277ba2053
834241febuxostat 80 MG Oral TabletSCD0629ab39-196e-4198-902a-3c16277ba2053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1552-0707711552001000 TABLET in 1 BOTTLE (70771-1552-0) 1000 tablet2023-03-31NoNoHistorical
70771-1552-170771155201100 TABLET in 1 BOTTLE (70771-1552-1) 100 tablet2023-03-31NoNoHistorical
70771-1552-37077115520330 TABLET in 1 BOTTLE (70771-1552-3) 30 tablet2023-03-31NoNoHistorical
70771-1552-47077115520410 BLISTER PACK in 1 CARTON (70771-1552-4) / 10 TABLET in 1 BLISTER PACK10 blister pack2023-03-31NoNoHistorical
70771-1552-570771155205500 TABLET in 1 BOTTLE (70771-1552-5) 500 tablet2023-03-31NoNoHistorical
70771-1552-97077115520990 TABLET in 1 BOTTLE (70771-1552-9) 90 tablet2023-03-31NoNoHistorical