NDC 42385-935

FENOFIBRATE

Fenofibrate

FENOFIBRATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Fenofibrate.

Product ID42385-935_577be450-71e7-4864-87f2-daf2fc004082
NDC42385-935
Product TypeHuman Prescription Drug
Proprietary NameFENOFIBRATE
Generic NameFenofibrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA210606
Labeler NameLaurus Labs 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 42385-935-05

500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)
Marketing Start Date2020-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42385-935-05 [42385093505]

FENOFIBRATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-13

NDC 42385-935-11 [42385093511]

FENOFIBRATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-13

NDC 42385-935-90 [42385093590]

FENOFIBRATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-13

NDC 42385-935-30 [42385093530]

FENOFIBRATE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-13

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRATE54 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
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