OXCARBAZEPINE
These highlights do not include all the information needed to use OXCARBAZEPINE ORAL SUSPENSION safely and effectively. See full prescribing information for OXCARBAZEPINE ORAL SUSPENSION. OXCARBAZEPINE oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
4ef6a941-a017-40f2-a50a-ab66c43b3347
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
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 Code72888-074
Application NumberANDA215726
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXCARBAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (12)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXCARBAZEPINEActive
Quantity: 300 mg in 5 mL
Code: VZI5B1W380
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT