NDC 69916-105

FIBRICOR

Fenofibric Acid

FIBRICOR is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Tribute Pharmaceuticals Us, Inc.. The primary component is Fenofibric Acid.

Product ID69916-105_31112335-e6c0-4c10-b5db-8cf4c4c74d65
NDC69916-105
Product TypeHuman Prescription Drug
Proprietary NameFIBRICOR
Generic NameFenofibric Acid
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-30
Marketing CategoryNDA / NDA
Application NumberNDA022418
Labeler NameTribute Pharmaceuticals US, Inc.
Substance NameFENOFIBRIC ACID
Active Ingredient Strength105 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69916-105-30

30 TABLET in 1 BOTTLE, PLASTIC (69916-105-30)
Marketing Start Date2015-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69916-105-30 [69916010530]

FIBRICOR TABLET
Marketing CategoryNDA
Application NumberNDA022418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30
Inactivation Date2020-01-31

NDC 69916-105-07 [69916010507]

FIBRICOR TABLET
Marketing CategoryNDA
Application NumberNDA022418
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-08
Inactivation Date2020-01-31

NDC 69916-105-90 [69916010590]

FIBRICOR TABLET
Marketing CategoryNDA
Application NumberNDA022418
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30
Inactivation Date2020-01-31

NDC 69916-105-10 [69916010510]

FIBRICOR TABLET
Marketing CategoryNDA
Application NumberNDA022418
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRIC ACID105 mg/1

OpenFDA Data

SPL SET ID:777b0c6b-cd25-454d-a35b-d2df9b44497f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860880
  • 860888
  • 860884
  • 860886
    • UPC Code
  • 0369916035309
  • 0369916105309

    • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    NDC Crossover Matching brand name "FIBRICOR" or generic name "Fenofibric Acid"

    NDCBrand NameGeneric Name
    13310-101FIBRICORFenofibric Acid
    13310-102FIBRICORFenofibric Acid
    69916-035FIBRICORFIBRICOR
    69916-105FIBRICORFIBRICOR
    70347-105FIBRICORFIBRICOR
    70347-035FIBRICORFIBRICOR
    49708-102FIBRICORFIBRICOR
    49708-101FIBRICORFIBRICOR
    71511-501FIBRICORFIBRICOR
    71511-502FIBRICORFIBRICOR
    0115-1554Fenofibric AcidFenofibric Acid
    0115-1555Fenofibric AcidFenofibric Acid
    0228-2838fenofibric acidfenofibric acid
    0228-2839fenofibric acidfenofibric acid
    0378-2589Fenofibric Acidfenofibric acid
    0378-2590Fenofibric Acidfenofibric acid
    10370-209Fenofibric AcidFenofibric Acid
    10370-210Fenofibric AcidFenofibric Acid
    24979-109Fenofibric AcidFenofibric Acid
    24979-112Fenofibric AcidFenofibric Acid
    42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACID
    42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric Acid
    0074-3161TrilipixFenofibric Acid
    0074-3162TrilipixFenofibric Acid
    0074-9189TrilipixFenofibric Acid
    0074-9642TrilipixFenofibric Acid

    Trademark Results [FIBRICOR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIBRICOR
    FIBRICOR
    77574728 3729598 Live/Registered
    ATHENA BIOSCIENCE, LLC
    2008-09-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.