Oxcarbazepine
Oxcarbazepine Tablets
Approved
Approval ID
e8a485af-a78b-49a0-9bf4-75e1cd5bb740
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-864
Application NumberANDA077802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2009
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
OXCARBAZEPINEActive
Quantity: 600 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-862
Application NumberANDA077802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2009
FDA Product Classification
INGREDIENTS (10)
OXCARBAZEPINEActive
Quantity: 150 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-863
Application NumberANDA077802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2009
FDA Product Classification
INGREDIENTS (10)
OXCARBAZEPINEActive
Quantity: 300 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT