Fenofibrate

Product NDC
42043-170
11-digit product format
420430170
Labeler code
42043
Product ID
42043-170_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Karalex Pharma LLC
Application
ANDA076520
Marketing category
ANDA
Marketing start
2009-11-20
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record