NDC 66869-137

LIPOFEN

Fenofibrate

LIPOFEN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Kowa Pharmaceuticals America Inc.. The primary component is Fenofibrate.

Product ID66869-137_1d1631cb-e41b-4082-aaad-4b2433dfa741
NDC66869-137
Product TypeHuman Prescription Drug
Proprietary NameLIPOFEN
Generic NameFenofibrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-10-01
Marketing CategoryNDA / NDA
Application NumberNDA021612
Labeler NameKowa Pharmaceuticals America Inc.
Substance NameFENOFIBRATE
Active Ingredient Strength50 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66869-137-20

30 CAPSULE in 1 BOTTLE, PLASTIC (66869-137-20)
Marketing Start Date2007-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66869-137-30 [66869013730]

LIPOFEN CAPSULE
Marketing CategoryNDA
Application NumberNDA021612
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-01

NDC 66869-137-20 [66869013720]

LIPOFEN CAPSULE
Marketing CategoryNDA
Application NumberNDA021612
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-01

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE50 mg/1

OpenFDA Data

SPL SET ID:9a883573-aa2a-4376-bb0f-3b88246d2169
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616852
  • 616853
  • 702169
  • 702055
  • UPC Code
  • 0366869137302
  • 0366869147301
  • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    Medicade Reported Pricing

    66869013730 LIPOFEN 50 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    66869-147LIPOFENLIPOFEN
    66869-137LIPOFENLIPOFEN
    0093-7755FenofibrateFenofibrate
    0093-7756FenofibrateFenofibrate
    0115-0511FenofibrateFENOFIBRATE
    0115-0522FenofibrateFENOFIBRATE
    0115-0533FenofibrateFENOFIBRATE
    0115-1522FenofibrateFenofibrate
    0115-1523FenofibrateFenofibrate
    0115-5511FENOFIBRATEFENOFIBRATE
    0115-5522FENOFIBRATEFENOFIBRATE
    0074-3173TricorFenofibrate
    0074-3189TricorFenofibrate

    Trademark Results [LIPOFEN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LIPOFEN
    LIPOFEN
    78688955 3403114 Live/Registered
    Cipher Pharmaceuticals Inc.
    2005-08-09

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