FDA.reportPublic FDA data

Fenofibrate

Product NDC
71335-3086
11-digit product format
713353086
Labeler code
71335
Product ID
71335-3086_8da3cdaa-ead4-4a80-8347-df88e83d0f08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216798
Marketing category
ANDA
Marketing start
2022-09-27
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287

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
71335-3086-1Fenofibrate30 in 1 BOTTLETABLET, FILM COATED301
71335-3086-2Fenofibrate90 in 1 BOTTLETABLET, FILM COATED901
71335-3086-3Fenofibrate60 in 1 BOTTLETABLET, FILM COATED601
71335-3086-4Fenofibrate28 in 1 BOTTLETABLET, FILM COATED281
71335-3086-5Fenofibrate100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNbbeae8e4-e06a-4c19-a1b9-f6143306dab91
349287fenofibrate 160 MG Oral TabletSCDbbeae8e4-e06a-4c19-a1b9-f6143306dab91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3086-17133530860130 TABLET, FILM COATED in 1 BOTTLE (71335-3086-1) 2026-02-16NoNoHistorical
71335-3086-27133530860290 TABLET, FILM COATED in 1 BOTTLE (71335-3086-2) 2026-02-16NoNoHistorical
71335-3086-37133530860360 TABLET, FILM COATED in 1 BOTTLE (71335-3086-3) 2026-02-16NoNoHistorical
71335-3086-47133530860428 TABLET, FILM COATED in 1 BOTTLE (71335-3086-4) 2026-02-16NoNoHistorical
71335-3086-571335308605100 TABLET, FILM COATED in 1 BOTTLE (71335-3086-5) 2026-02-16NoNoHistorical