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
fafbc0be-f0ba-4dcd-8aa5-89527bae5e84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2019
Manufacturers
FDA
NCS HealthCare of KY, Inc dba Vangard Labs
DUNS: 050052943
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 Code0615-8270
Application NumberANDA210138
Product Classification
M
Marketing Category
C73584
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2019
FDA Product Classification
INGREDIENTS (15)
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT