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
c53c20ed-a944-4b35-b5db-91d9f67240e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2021
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-7100
Application NumberANDA076520
Product Classification
M
Marketing Category
C73584
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2021
FDA Product Classification
INGREDIENTS (16)
FENOFIBRATEActive
Quantity: 54 mg in 1 1
Code: U202363UOS
Classification: ACTIB
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-7101
Application NumberANDA076520
Product Classification
M
Marketing Category
C73584
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2021
FDA Product Classification
INGREDIENTS (14)
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT