TRILEPTAL
OXCARBAZEPINE
Approved
Approval ID
33af9350-95f3-384e-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2016
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
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 Code61919-569
Application NumberANDA077802
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXCARBAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2016
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OXCARBAZEPINEActive
Quantity: 300 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT