Lipofen
These highlights do not include all the information needed to use LIPOFEN safely and effectively. See full prescribing information for LIPOFEN. LIPOFEN (fenofibrate capsules, USP) for oral use Initial U.S. Approval: 1993
Approved
Approval ID
78b789b9-854f-46b9-97f3-a48759a6ff89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2021
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-306
Application NumberNDA021612
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2021
FDA Product Classification
INGREDIENTS (13)
FENOFIBRATEActive
Quantity: 150 mg in 1 1
Code: U202363UOS
Classification: ACTIB
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369M
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-305
Application NumberNDA021612
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2021
FDA Product Classification
INGREDIENTS (15)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT
FENOFIBRATEActive
Quantity: 50 mg in 1 1
Code: U202363UOS
Classification: ACTIB
LAUROYL PEG-32 GLYCERIDESInactive
Code: H5ZC52369M
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (160000 WAMW)Inactive
Code: 0A7M0N7SPE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT