NDC 68012-490

Fenoglide

Fenofibrate

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

Product ID68012-490_111abed0-61c5-49ad-b381-d3a20540cd19
NDC68012-490
Product TypeHuman Prescription Drug
Proprietary NameFenoglide
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-11-18
Marketing CategoryNDA / NDA
Application NumberNDA022118
Labeler NameSantarus, Inc.
Substance NameFENOFIBRATE
Active Ingredient Strength40 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68012-490-90

90 TABLET in 1 BOTTLE (68012-490-90)
Marketing Start Date2010-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68012-490-90 [68012049090]

Fenoglide TABLET
Marketing CategoryNDA
Application NumberNDA022118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-11-18

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE40 mg/1

OpenFDA Data

SPL SET ID:35e89d4e-45cf-4374-bf93-fca8d40d783b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749802
  • 749804
  • 763250
  • 763252
  • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    NDC Crossover Matching brand name "Fenoglide" or generic name "Fenofibrate"

    NDCBrand NameGeneric Name
    68012-490FenoglideFenoglide
    68012-495FenoglideFenoglide
    52725-490FenoglideFenoglide
    52725-495FenoglideFenoglide
    0093-7755FenofibrateFenofibrate
    0093-7756FenofibrateFenofibrate
    0115-0511FenofibrateFENOFIBRATE
    0115-0522FenofibrateFENOFIBRATE
    0115-0533FenofibrateFENOFIBRATE
    0115-1522FenofibrateFenofibrate
    0115-1523FenofibrateFenofibrate
    0115-5511FENOFIBRATEFENOFIBRATE
    0115-5522FENOFIBRATEFENOFIBRATE
    0074-3173TricorFenofibrate
    0074-3189TricorFenofibrate

    Trademark Results [Fenoglide]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FENOGLIDE
    FENOGLIDE
    77381746 3528941 Live/Registered
    SANTARUS, INC.
    2008-01-28

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