Fenofibrate
These highlights do not include all the information needed to use Fenofibrate Tablets USP safely and effectively. See full prescribing information for Fenofibrate Tablets USP.FENOFIBRATE Tablets USP for Oral useInitial U.S. Approval: 1993
Approved
Approval ID
98316140-765f-4501-a774-88514763a524
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2016
Manufacturers
FDA
LUPIN LIMITED
DUNS: 675923163
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 Code57297-361
Application NumberANDA090856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2016
FDA Product Classification
INGREDIENTS (13)
FENOFIBRATEActive
Quantity: 145 mg in 1 1
Code: U202363UOS
Classification: ACTIB
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT