NDC 0615-7548

Fenofibrate

Fenofibrate

Fenofibrate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Fenofibrate.

Product ID0615-7548_bdda5eba-bfcc-42e3-834f-860e08d72d82
NDC0615-7548
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate
Generic NameFenofibrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA075868
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameFENOFIBRATE
Active Ingredient Strength200 mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7548-31

31 CAPSULE in 1 BLISTER PACK (0615-7548-31)
Marketing Start Date2010-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7548-39 [00615754839]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA075868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-01
Inactivation Date2020-01-31

NDC 0615-7548-31 [00615754831]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA075868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-25
Inactivation Date2020-01-31

NDC 0615-7548-05 [00615754805]

Fenofibrate CAPSULE
Marketing CategoryANDA
Application NumberANDA075868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE200 mg/1

OpenFDA Data

SPL SET ID:e5e78bfc-1b18-46fa-aebd-f8ae313960c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310289
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.