FENOFIBRATE

Product NDC
0615-8530
11-digit product format
006158530
Labeler code
0615
Product ID
0615-8530_f714d278-9ca8-4cb1-8724-4fe6991e2e3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA208709
Marketing category
ANDA
Marketing start
2016-12-15
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
0615-8530-390061585303930 TABLET in 1 BLISTER PACK (0615-8530-39) 30 tablet2024-09-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FENOFIBRATENCS HealthCare of KY, LLC dba Vangard Labs2024-10-01HUMAN PRESCRIPTION DRUG LABEL1