NDC 42043-170

Fenofibrate

Fenofibrate

Fenofibrate is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Karalex Pharma Llc. The primary component is Fenofibrate.

Product ID42043-170_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e
NDC42043-170
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate
Generic NameFenofibrate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2009-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA076520
Labeler NameKaralex Pharma LLC
Substance NameFENOFIBRATE
Active Ingredient Strength54 mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 42043-170-09

90 TABLET, COATED in 1 BOTTLE (42043-170-09)
Marketing Start Date2009-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42043-170-09 [42043017009]

Fenofibrate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA076520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-20
Marketing End Date2009-11-20

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE54 mg/1

OpenFDA Data

SPL SET ID:04cbb126-4357-42f6-9c89-6fa9ff475b34
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349287
  • 351133

    • Pharmacological Class

    • Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
    • PPAR alpha [CS]
    • 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
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