Oxcarbazepine
These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE film-coated tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
c0f9df3f-280e-4394-8d7e-ad04803b2635
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 3
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 Code60687-711
Application NumberANDA215939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
OXCARBAZEPINEActive
Quantity: 150 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-722
Application NumberANDA215939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
OXCARBAZEPINEActive
Quantity: 300 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-733
Application NumberANDA215939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXCARBAZEPINEActive
Quantity: 600 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT