Oxcarbazepine
These highlights do not include all the information needed to use oxcarbazepine oral suspension, USP safely and effectively. See full prescribing information for oxcarbazepine oral suspension, USP.Oxcarbazepine oral suspension, USP for oral administrationInitial U.S. Approval: 2000
Approved
Approval ID
ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2015
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
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 Code63304-653
Application NumberANDA078734
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2015
FDA Product Classification
INGREDIENTS (16)
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
OXCARBAZEPINEActive
Quantity: 60 mg in 1 mL
Code: VZI5B1W380
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PEG-8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT