Fenofibrate
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
Approved
Approval ID
d9be3ae3-6da9-47fd-bcfd-e561b9d585ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2025
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7480
Application NumberANDA090856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (9)
FENOFIBRATEActive
Quantity: 145 mg in 1 1
Code: U202363UOS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT