NDC 0378-4390

Fenofibrate

Fenofibrate

Fenofibrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fenofibrate.

Product ID0378-4390_0861e52e-72f0-489e-8b25-e545620ac26a
NDC0378-4390
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-23
Marketing CategoryANDA / ANDA
Application NumberANDA204475
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFENOFIBRATE
Active Ingredient Strength40 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-4390-77

90 TABLET in 1 BOTTLE, PLASTIC (0378-4390-77)
Marketing Start Date2016-06-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4390-77 [00378439077]

Fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA204475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-23

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE40 mg/1

OpenFDA Data

SPL SET ID:5b67f389-55e8-466b-82bd-5ea992f630aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749802
  • 749804
    • UPC Code
  • 0303784390771

    • 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
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