Fenofibrate

Product NDC
71335-0872
11-digit product format
713350872
Labeler code
71335
Product ID
71335-0872_de559204-8191-4de6-93f7-b817cb6d9d6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200884
Marketing category
ANDA
Marketing start
2018-06-01
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fenofibrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE145 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui477560

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0872-1Fenofibrate30 in 1 BOTTLETABLET, FILM COATED305
71335-0872-2Fenofibrate90 in 1 BOTTLETABLET, FILM COATED905
71335-0872-3Fenofibrate28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0872FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 3 package rows20250331_3db58c5c-b862-4871-b3f9-597aaeba56c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN3db58c5c-b862-4871-b3f9-597aaeba56c45
477560fenofibrate 145 MG Oral TabletSCD3db58c5c-b862-4871-b3f9-597aaeba56c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0872-17133508720130 TABLET, FILM COATED in 1 BOTTLE (71335-0872-1) 2019-03-070000-00-00NoNoCurrent
71335-0872-27133508720290 TABLET, FILM COATED in 1 BOTTLE (71335-0872-2) 2018-06-200000-00-00NoNoCurrent
71335-0872-37133508720328 TABLET, FILM COATED in 1 BOTTLE (71335-0872-3) 2021-12-270000-00-00NoNoCurrent