FENOFIBRIC ACID DELAYED-RELEASE
These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsule for oral use Initial U.S. Approval: 2008
Approved
Approval ID
302ffbf8-448e-4729-949f-40d457e30ab4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2022
Manufacturers
FDA
Laurus Labs Limited
DUNS: 915075687
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-945
Application NumberANDA211626
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (22)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FENOFIBRIC ACIDActive
Quantity: 135 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
FENOFIBRIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-944
Application NumberANDA211626
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOFIBRIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (20)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FENOFIBRIC ACIDActive
Quantity: 45 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT