NDC 43547-431

FENOFIBRATE

Fenofibrate

FENOFIBRATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Fenofibrate.

Product ID43547-431_085109a6-f006-44f0-a170-980d8899a365
NDC43547-431
Product TypeHuman Prescription Drug
Proprietary NameFENOFIBRATE
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA211080
Labeler NameSolco Healthcare US, LLC
Substance NameFENOFIBRATE
Active Ingredient Strength145 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43547-431-09

90 TABLET in 1 BOTTLE (43547-431-09)
Marketing Start Date2019-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-431-50 [43547043150]

FENOFIBRATE TABLET
Marketing CategoryANDA
Application NumberANDA211080
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-20

NDC 43547-431-09 [43547043109]

FENOFIBRATE TABLET
Marketing CategoryANDA
Application NumberANDA211080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-20

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE145 mg/1

OpenFDA Data

SPL SET ID:085109a6-f006-44f0-a170-980d8899a365
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477562
  • 477560

    • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]
    • 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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