Fenofibrate
These highlights do not include all the information needed to use FENOFIBRATE capsules safely and effectively. See full prescribing information for FENOFIBRATE capsules.FENOFIBRATE Capsules, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
37b25526-0bd0-4459-a4be-f3a6893506f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 2
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 Code68180-131
Application NumberNDA021695
Product Classification
M
Marketing Category
C73605
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (15)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FENOFIBRATEActive
Quantity: 130 mg in 1 1
Code: U202363UOS
Classification: ACTIB
D&C BLACK NO. 2Inactive
Code: 4XYU5U00C4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SULFUR DIOXIDEInactive
Code: 0UZA3422Q4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-130
Application NumberNDA021695
Product Classification
M
Marketing Category
C73605
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
INGREDIENTS (15)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SULFUR DIOXIDEInactive
Code: 0UZA3422Q4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FENOFIBRATEActive
Quantity: 43 mg in 1 1
Code: U202363UOS
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT