Trilipix
These highlights do not include all the information needed to use Trilipix safely and effectively. See full prescribing information for Trilipix.Trilipix (fenofibric acid) capsule, delayed release for oral useInitial U.S. Approval: 2008
Approved
Approval ID
3057fc9c-ff77-43eb-b687-776660423742
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5986
Application NumberNDA022224
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2011
FDA Product Classification
INGREDIENTS (13)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FENOFIBRIC ACIDActive
Quantity: 135 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT