Fenofibrate

Product NDC
50090-7209
11-digit product format
500907209
Labeler code
50090
Product ID
50090-7209_2aae8e1f-04c2-46dd-9c83-8effb5193571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
U202363UOSFENOFIBRATE49562-28-9FENOFIBRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7209-05009072090090 TABLET, FILM COATED in 1 BOTTLE (50090-7209-0) 2024-08-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FenofibrateA-S Medication Solutions2025-10-16Human Prescription Drug Label4
FenofibrateA-S Medication Solutions2024-08-07Human Prescription Drug Label2