Trileptal
These highlights do not include all the information needed to use Trileptal safely and effectively. See full prescribing information for Trileptal . Trileptal ( oxcarbazepine ) film-coated tablets Trileptal ( oxcarbazepine ) oral suspension for oral administration Initial U.S. Approval: 2000
Approved
Approval ID
d9741f36-0abd-49b7-9f43-e9700663122b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4837
Application NumberNDA021014
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2012
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
OXCARBAZEPINEActive
Quantity: 300 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4836
Application NumberNDA021014
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2012
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXCARBAZEPINEActive
Quantity: 150 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT