NDC 50742-201

FENOFIBRATE

Fenofibrate

FENOFIBRATE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Fenofibrate.

Product ID50742-201_06020ee2-603b-4314-b422-66a27e83dc8d
NDC50742-201
Product TypeHuman Prescription Drug
Proprietary NameFENOFIBRATE
Generic NameFenofibrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA207564
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameFENOFIBRATE
Active Ingredient Strength67 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50742-201-01

100 CAPSULE in 1 BOTTLE (50742-201-01)
Marketing Start Date2019-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-201-05 [50742020105]

FENOFIBRATE CAPSULE
Marketing CategoryANDA
Application NumberANDA207564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-25

NDC 50742-201-01 [50742020101]

FENOFIBRATE CAPSULE
Marketing CategoryANDA
Application NumberANDA207564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-25

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE67 mg/1

Pharmacological Class

  • Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC Crossover Matching brand name "FENOFIBRATE" or generic name "Fenofibrate"

NDCBrand NameGeneric Name
0093-7755FenofibrateFenofibrate
0093-7756FenofibrateFenofibrate
0115-0511FenofibrateFENOFIBRATE
0115-0522FenofibrateFENOFIBRATE
0115-0533FenofibrateFENOFIBRATE
0115-1522FenofibrateFenofibrate
0115-1523FenofibrateFenofibrate
0115-5511FENOFIBRATEFENOFIBRATE
0115-5522FENOFIBRATEFENOFIBRATE
68071-2021FenofibrateFenofibrate
68071-1601FenofibrateFenofibrate
68071-2135FenofibrateFenofibrate
68071-3300FenofibrateFenofibrate
68071-3114fenofibratefenofibrate
68071-2042FenofibrateFenofibrate
68071-2115FenofibrateFenofibrate
68071-4264FenofibrateFenofibrate
68071-4289FenofibrateFenofibrate
68071-4297FenofibrateFenofibrate
68071-4320fenofibratefenofibrate
68071-4310FenofibrateFenofibrate
68071-4486FenofibrateFenofibrate
68071-4088FenofibrateFenofibrate
68071-4182fenofibratefenofibrate
68071-4265fenofibratefenofibrate
68071-4692FenofibrateFenofibrate
68071-4557FENOFIBRATEFENOFIBRATE
68071-4358fenofibratefenofibrate
68071-4659FenofibrateFenofibrate
68084-636FenofibrateFenofibrate
68084-328FENOFIBRATEFENOFIBRATE
68084-827FENOFIBRATEFENOFIBRATE
68084-329FenofibrateFenofibrate
68084-635FenofibrateFenofibrate
68084-835FenofibrateFenofibrate
68151-4717FenofibrateFenofibrate
68151-4718FenofibrateFenofibrate
68180-130FenofibrateFenofibrate
68180-131FenofibrateFenofibrate
68180-360FenofibrateFenofibrate
68180-363FenofibrateFenofibrate
68180-362FenofibrateFenofibrate
68180-361FenofibrateFenofibrate
68382-270FenofibrateFenofibrate
68382-269FenofibrateFenofibrate
68462-581fenofibratefenofibrate
68462-582fenofibratefenofibrate
68462-580fenofibratefenofibrate
68788-7000FenofibrateFenofibrate
68788-6330FenofibrateFenofibrate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.