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 USP, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
d22df203-ec60-2f0e-e053-2995a90a41bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2587
Application NumberANDA204598
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FENOFIBRATEActive
Quantity: 145 mg in 1 1
Code: U202363UOS
Classification: ACTIB