Fenofibric Acid
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 capsules for oral useInitial U.S. Approval: 2008
Approved
Approval ID
44d45479-f8d5-436d-8937-bb333b0a3567
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-112
Application NumberANDA210469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2020
FDA Product Classification
INGREDIENTS (19)
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
CHOLINE FENOFIBRATEActive
Quantity: 135 mg in 1 1
Code: 4BMH7IZT98
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-109
Application NumberANDA210469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2020
FDA Product Classification
INGREDIENTS (18)
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133
Classification: IACT
CHOLINE FENOFIBRATEActive
Quantity: 45 mg in 1 1
Code: 4BMH7IZT98
Classification: ACTIM
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT