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Fenofibrate

These highlights do not include all the information needed to use fenofibrate tablet safely and effectively. See full prescribing information for fenofibrate tablet. FENOFIBRATE Tablets USP, 54 mg and 160 mg for oral use Initial U.S. Approval: 1993

Approved
Approval ID

1d167b24-eb16-48ea-8a97-048cfad6ba62

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2019

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fenofibrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63187-681
Application NumberANDA204019
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification

INGREDIENTS (15)

FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT

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Fenofibrate - FDA Drug Approval Details