Fenofibrate
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE TABLETS for oral use Initial U.S. Approval: 1993
Approved
Approval ID
4387adac-eea0-40c5-8111-1b70e0d98d7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-539
Application NumberANDA209660
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2021
FDA Product Classification
INGREDIENTS (14)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-538
Application NumberANDA209660
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2021
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FENOFIBRATEActive
Quantity: 54 mg in 1 1
Code: U202363UOS
Classification: ACTIB