Oxcarbazepine
Oxcarbazepine Tablets
Approved
Approval ID
abbf6b75-bc22-42af-ae08-445d8c186092
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-842
Application NumberANDA077794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2014
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
OXCARBAZEPINEActive
Quantity: 600 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-841
Application NumberANDA077794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2014
FDA Product Classification
INGREDIENTS (12)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
OXCARBAZEPINEActive
Quantity: 300 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Oxcarbazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-684
Application NumberANDA077794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2014
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OXCARBAZEPINEActive
Quantity: 150 mg in 1 1
Code: VZI5B1W380
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT