NDC 0378-2589

Fenofibric Acid

Fenofibric Acid

Fenofibric Acid is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fenofibric Acid.

Product ID0378-2589_5c506b03-234c-420a-af44-3b08f4f80540
NDC0378-2589
Product TypeHuman Prescription Drug
Proprietary NameFenofibric Acid
Generic NameFenofibric Acid
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing End Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA200913
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFENOFIBRIC ACID
Active Ingredient Strength45 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-2589-77

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2589-77)
Marketing Start Date2013-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2589-05 [00378258905]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA200913
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15
Marketing End Date2015-06-04

NDC 0378-2589-93 [00378258993]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA200913
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15
Marketing End Date2015-06-04

NDC 0378-2589-77 [00378258977]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA200913
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-15
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRIC ACID45 mg/1

OpenFDA Data

SPL SET ID:05f08d62-9de9-4af9-931e-10b93c70e39e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828373
  • 828379
  • UPC Code
  • 0303782590777
  • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

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

    NDCBrand NameGeneric Name
    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
    68180-128Fenofibric acidFenofibric acid
    68180-129Fenofibric acidFenofibric acid
    68382-232Fenofibric AcidFenofibric Acid
    68382-233Fenofibric AcidFenofibric Acid
    69973-035Fenofibric AcidFenofibric Acid
    69973-105Fenofibric AcidFenofibric Acid
    46708-245Fenofibric AcidFenofibric Acid
    46708-244Fenofibric AcidFenofibric Acid
    53489-678Fenofibric AcidFenofibric Acid
    53489-677Fenofibric AcidFenofibric Acid
    62332-245Fenofibric AcidFenofibric Acid
    62332-244Fenofibric AcidFenofibric Acid
    50090-4373Fenofibric acidFenofibric acid
    59651-217FENOFIBRIC ACIDFENOFIBRIC ACID
    59651-216FENOFIBRIC ACIDFENOFIBRIC ACID
    50090-4561Fenofibric AcidFenofibric Acid
    72834-105Fenofibric AcidFenofibric Acid
    72834-035Fenofibric AcidFenofibric Acid
    68134-602Fenofibric AcidFenofibric Acid
    42571-348Fenofibric acidFenofibric acid
    68134-601Fenofibric AcidFenofibric Acid
    42571-347Fenofibric acidFenofibric acid
    42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACID
    42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric Acid
    13310-101FIBRICORFenofibric Acid
    13310-102FIBRICORFenofibric Acid
    0074-3161TrilipixFenofibric Acid
    0074-3162TrilipixFenofibric Acid
    0074-9189TrilipixFenofibric Acid
    0074-9642TrilipixFenofibric Acid

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