NDC 63304-444

Fenofibrate

Fenofibrate

Fenofibrate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Fenofibrate.

Product ID63304-444_08eb7fa6-bece-43e2-bed8-ef3d06a785a6
NDC63304-444
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate
Generic NameFenofibrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA201748
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameFENOFIBRATE
Active Ingredient Strength130 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63304-444-05

500 CAPSULE in 1 BOTTLE (63304-444-05)
Marketing Start Date2015-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-444-05 [63304044405]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA201748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-02

NDC 63304-444-90 [63304044490]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA201748
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-02

NDC 63304-444-30 [63304044430]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA201748
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-02

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE130 mg/1

OpenFDA Data

SPL SET ID:2083f5d9-92f2-4c64-b996-fabbd6946ea0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 483425
  • 483427
  • UPC Code
  • 0363304443301
  • 0363304444308
  • 0363304444902
  • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    Medicade Reported Pricing

    63304044490 FENOFIBRATE 130 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    63304044430 FENOFIBRATE 130 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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.