Fenofibrate
Fenofibrate Capsules USP Rx only
Approved
Approval ID
05957860-eab3-4172-9877-455540d0c922
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
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 Code59651-202
Application NumberANDA212232
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (15)
FENOFIBRATEActive
Quantity: 134 mg in 1 1
Code: U202363UOS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-203
Application NumberANDA212232
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FENOFIBRATEActive
Quantity: 200 mg in 1 1
Code: U202363UOS
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-201
Application NumberANDA212232
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (16)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FENOFIBRATEActive
Quantity: 67 mg in 1 1
Code: U202363UOS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT