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
d3684d55-0564-4849-bdf6-b91f22a3e28c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Marlex Pharmaceuticals, Inc
DUNS: 782540215
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 Code10135-798
Application NumberANDA217782
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxcarbazepine
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (13)
OxcarbazepineActive
Quantity: 300 mg in 5 mL
Code: VZI5B1W380
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYOXYL STEARATE 40Inactive
Code: 13A4J4NH9I
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT