NDC 69844-008

Fenofibrate film coated

Fenofibrate

Fenofibrate film coated is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Graviti Pharmaceuticals Private Limited. The primary component is Fenofibrate.

Product ID69844-008_277e7791-b247-487c-ba5f-d3094d0cd7bc
NDC69844-008
Product TypeHuman Prescription Drug
Proprietary NameFenofibrate film coated
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA210606
Labeler NameGraviti Pharmaceuticals Private Limited
Substance NameFENOFIBRATE
Active Ingredient Strength54 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69844-008-01

30 TABLET in 1 BOTTLE (69844-008-01)
Marketing Start Date2018-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69844-008-02 [69844000802]

Fenofibrate film coated TABLET
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17

NDC 69844-008-03 [69844000803]

Fenofibrate film coated TABLET
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17

NDC 69844-008-01 [69844000801]

Fenofibrate film coated TABLET
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE54 mg/1

OpenFDA Data

SPL SET ID:02ccab68-c620-4867-8cdd-f4364185dca8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349287
  • 351133
    • UPC Code
  • 0369844009014
  • 0369844008017

    • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    NDC Crossover Matching brand name "Fenofibrate film coated" or generic name "Fenofibrate"

    NDCBrand NameGeneric Name
    69844-008Fenofibrate film coatedFenofibrate film coated
    69844-009Fenofibrate film coatedFenofibrate film coated
    0093-7755FenofibrateFenofibrate
    0093-7756FenofibrateFenofibrate
    0115-0511FenofibrateFENOFIBRATE
    0115-0522FenofibrateFENOFIBRATE
    0115-0533FenofibrateFENOFIBRATE
    0115-1522FenofibrateFenofibrate
    0115-1523FenofibrateFenofibrate
    0115-5511FENOFIBRATEFENOFIBRATE
    0115-5522FENOFIBRATEFENOFIBRATE
    0074-3173TricorFenofibrate
    0074-3189TricorFenofibrate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.