fenofibrate

Product NDC
71335-2413
11-digit product format
713352413
Labeler code
71335
Product ID
71335-2413_aeee81bb-b8cf-4b57-bc85-813fcc74c79d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211122
Marketing category
ANDA
Marketing start
2022-07-18
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U202363UOSFENOFIBRATE49562-28-9FENOFIBRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2413-17133524130130 TABLET in 1 BOTTLE (71335-2413-1) 30 tablet2024-10-11NoNoHistorical
71335-2413-27133524130290 TABLET in 1 BOTTLE (71335-2413-2) 90 tablet2024-05-29NoNoHistorical
71335-2413-37133524130328 TABLET in 1 BOTTLE (71335-2413-3) 28 tablet2025-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
fenofibrateBryant Ranch Prepack2025-01-31HUMAN PRESCRIPTION DRUG LABEL2