Tricor
TRICOR® 48 mg and 145 mg (fenofibrate tablets)
Approved
Approval ID
194cd14a-d952-4507-91be-3f1d5371d3b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-5224
Application NumberNDA021656
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2010
FDA Product Classification
INGREDIENTS (16)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FENOFIBRATEActive
Quantity: 48 mg in 1 1
Code: U202363UOS
Classification: ACTIM
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4597
Application NumberNDA021203
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2010
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIM
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5203
Application NumberNDA021656
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2010
FDA Product Classification
INGREDIENTS (13)
FENOFIBRATEActive
Quantity: 145 mg in 1 1
Code: U202363UOS
Classification: ACTIM
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT