NDC 0115-1555

Fenofibric Acid

Fenofibric Acid

Fenofibric Acid is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Fenofibric Acid.

Product ID0115-1555_0758938f-2318-5305-df79-2f1852f308d1
NDC0115-1555
Product TypeHuman Prescription Drug
Proprietary NameFenofibric Acid
Generic NameFenofibric Acid
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-09-12
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022224
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameFENOFIBRIC ACID
Active Ingredient Strength135 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0115-1555-10

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1555-10)
Marketing Start Date2016-09-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1555-10 [00115155510]

Fenofibric Acid CAPSULE, DELAYED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022224
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-12

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRIC ACID135 mg/1

OpenFDA Data

SPL SET ID:369b3e55-2c05-d879-fe7e-91296c529ae9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828373
  • 828379
    • UPC Code
  • 0301151459106
  • 0301151460102
  • 0301151554108

    • 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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