Fenofibrate
These highlights do not include all the information needed to use FENOFIBRATE TABLETS, USP safely and effectively. See full prescribing information for FENOFIBRATE TABLETS, USP. FENOFIBRATE TABLETS, USP, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
66761695-8630-49ff-8264-965dee246437
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2025
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-853
Application NumberANDA076433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2025
FDA Product Classification
INGREDIENTS (18)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FENOFIBRATEActive
Quantity: 54 mg in 1 1
Code: U202363UOS
Classification: ACTIB
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-864
Application NumberANDA076433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2025
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/1/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/1/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 9/1/2024
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 9/1/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 9/1/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 9/1/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/1/2024
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 9/1/2024
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 9/1/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 9/1/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 9/1/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 9/1/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 9/1/2024
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 9/1/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 9/1/2024
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 9/1/2024
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/1/2024
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 2/26/2025