MedPath
FDA Product

fenofibrate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

fenofibrate

50090-5244

Regulatory Information

50090-5244

ANDA210138

C73584

December 29, 2021

USA

These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

Human Prescription Drug Label

5

Company Information

830016429

Active Ingredients

FENOFIBRATE

Quantity: 54 mg in 1 1

Code: U202363UOS

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A CORN

Code: AG9B65PV6B

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

FENOFIBRIC ACID

Code: BGF9MN2HU1

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