NDC 68788-7578

fenofibrate

Fenofibrate

fenofibrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Fenofibrate.

Product ID68788-7578_162d1fe6-ab5a-47de-a6a3-cf621b05b0fb
NDC68788-7578
Product TypeHuman Prescription Drug
Proprietary Namefenofibrate
Generic NameFenofibrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-07-20
Marketing CategoryANDA / ANDA
Application NumberANDA210138
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameFENOFIBRATE
Active Ingredient Strength160 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68788-7578-1

100 TABLET in 1 BOTTLE (68788-7578-1)
Marketing Start Date2019-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7578-6 [68788757806]

fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA210138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7578-1 [68788757801]

fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA210138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7578-3 [68788757803]

fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA210138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7578-9 [68788757809]

fenofibrate TABLET
Marketing CategoryANDA
Application NumberANDA210138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE160 mg/1

Pharmacological Class

  • Peroxisome Proliferator Receptor alpha Agonist [EPC]

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

NDCBrand NameGeneric Name
0093-7755FenofibrateFenofibrate
0093-7756FenofibrateFenofibrate
0115-0511FenofibrateFENOFIBRATE
0115-0522FenofibrateFENOFIBRATE
0115-0533FenofibrateFENOFIBRATE
0115-1522FenofibrateFenofibrate
0115-1523FenofibrateFenofibrate
0115-5511FENOFIBRATEFENOFIBRATE
0115-5522FENOFIBRATEFENOFIBRATE
68071-2021FenofibrateFenofibrate
68071-1601FenofibrateFenofibrate
68071-2135FenofibrateFenofibrate
68071-3300FenofibrateFenofibrate
68071-3114fenofibratefenofibrate
68071-2042FenofibrateFenofibrate
68071-2115FenofibrateFenofibrate
68071-4264FenofibrateFenofibrate
68071-4289FenofibrateFenofibrate
68071-4297FenofibrateFenofibrate
68071-4320fenofibratefenofibrate
68071-4310FenofibrateFenofibrate
68071-4486FenofibrateFenofibrate
68071-4088FenofibrateFenofibrate
68071-4182fenofibratefenofibrate
68071-4265fenofibratefenofibrate
68071-4692FenofibrateFenofibrate
68071-4557FENOFIBRATEFENOFIBRATE
68071-4358fenofibratefenofibrate
68071-4659FenofibrateFenofibrate
68084-636FenofibrateFenofibrate
68084-328FENOFIBRATEFENOFIBRATE
68084-827FENOFIBRATEFENOFIBRATE
68084-329FenofibrateFenofibrate
68084-635FenofibrateFenofibrate
68084-835FenofibrateFenofibrate
68151-4717FenofibrateFenofibrate
68151-4718FenofibrateFenofibrate
68180-130FenofibrateFenofibrate
68180-131FenofibrateFenofibrate
68180-360FenofibrateFenofibrate
68180-363FenofibrateFenofibrate
68180-362FenofibrateFenofibrate
68180-361FenofibrateFenofibrate
68382-270FenofibrateFenofibrate
68382-269FenofibrateFenofibrate
68462-581fenofibratefenofibrate
68462-582fenofibratefenofibrate
68462-580fenofibratefenofibrate
68788-7000FenofibrateFenofibrate
68788-6330FenofibrateFenofibrate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.