NDC 57297-360

Fenofibrate

Fenofibrate

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

Product ID57297-360_a459212d-bef4-4911-b994-5f1c7b28b512
NDC57297-360
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-07-13
Marketing CategoryANDA / ANDA
Application NumberANDA090856
Labeler NameLUPIN LIMITED
Substance NameFENOFIBRATE
Active Ingredient Strength48 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-360-02

500 TABLET in 1 BOTTLE (57297-360-02)
Marketing Start Date2012-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-360-09 [57297036009]

Fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA090856
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-07-13
Inactivation Date2020-01-31

NDC 57297-360-02 [57297036002]

Fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA090856
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-07-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE48 mg/1

OpenFDA Data

SPL SET ID:98316140-765f-4501-a774-88514763a524
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477562
  • 477560
  • 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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