Regulatory PathRegulatory requirements compared

Active substance

Oxcarbazepine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CARPAZIO 150 MG FILM COATED TABLET150 mgFilm-coated tablet · Oral use50 BlisterSAR 31.40Generic · PrescriptionSPIMACO ADDWAEIHValid
CARPAZIO 300 MG FILM COATED TABLET300 mgFilm-coated tablet · Oral use50 BlisterSAR 45.40Generic · PrescriptionSPIMACO ADDWAEIHValid
CARPAZIO 600 MG FILM COATED TABLET600 mgFilm-coated tablet · Oral use50 BlisterSAR 74.50Generic · PrescriptionSPIMACO ADDWAEIHValid
TRILEPTAL 300MG F.C TAB300 mgFilm-coated tablet · Oral use50 BlisterSAR 46.30NCE · PrescriptionNOVARTIS PHARMA AGValid
TRILEPTAL 600MG F.C TAB600 mgFilm-coated tablet · Oral use50 BlisterSAR 84.85NCE · PrescriptionNOVARTIS PHARMA AGValid
TRILEPTAL 60MG\ML SUSPENTION60 mg/mlOral suspension · Oral use1 BottleSAR 123.80NCE · PrescriptionNOVARTIS PHARMA AGValid
TRILEPTAL 150MG F.C TAB150 mgFilm-coated tablet · Oral use50 BlisterSAR 35.85NCE · PrescriptionNOVARTIS PHARMA AGWithdrawn by MAH · Not Marketed
TRILEPTAL 150MG F.C TAB150 mgFilm-coated tablet · Oral use50 BlisterSAR 48.35NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
TRILEPTAL 300MG F.C TAB300 mgFilm-coated tablet · Oral use50 BlisterSAR 69.85NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
TRILEPTAL 600MG F.C TAB600 mgFilm-coated tablet · Oral use50 BlisterSAR 114.60NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
TRILEPTAL 60MG\ML SUSPENTION60 mg/mlOral suspension · Oral use1 BottleSAR 112.55NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BENIGN EPILEPSY WITH CENTROTEMPORAL SPIKES, PANAYIOTOPOULOS SYNDROME OR LATE-ONSET CHILDHOOD OCCIPITAL EPILEPSY (GASTAUT TYPE); TRIGEMINAL NEURALGIA

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
TRILEPTAL150MG; 300MG; 600MGtablet · oralNOVARTISPrescription14 Jan 2000
TRILEPTAL300MG/5MLsuspension · oralNOVARTISPrescription25 May 2001
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralSUN PHARM INDSPrescription9 Oct 2007
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralGLENMARK PHARMS LTDPrescription9 Oct 2007
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralTAROPrescription15 Nov 2007
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralANI PHARMSPrescription11 Dec 2007
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralBRECKENRIDGE PHARMPrescription11 Jan 2008
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralRUBICON RESEARCHPrescription9 Apr 2008
OXCARBAZEPINE300MG/5MLsuspension · oralSUN PHARM INDS LTDPrescription26 Jun 2009
OXCARBAZEPINE300MG/5MLsuspension · oralAMNEAL PHARMSPrescription17 Sep 2012
OXTELLAR XR150MG; 300MG; 600MGtablet, extended release · oralSUPERNUS PHARMSPrescription19 Oct 2012
OXCARBAZEPINE300MG/5MLsuspension · oralCHARTWELL RXPrescription21 Jun 2021
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralANNORA PHARMAPrescription11 Jan 2022
OXCARBAZEPINE300MG/5MLsuspension · oralRUBICON RESEARCHPrescription30 Aug 2022
OXCARBAZEPINE300MG/5MLsuspension · oralBIONPHARMAPrescription4 Nov 2022
OXCARBAZEPINE300MG/5MLsuspension · oralAUCTAPrescription30 Nov 2022
OXCARBAZEPINE150MG; 300MG; 600MGtablet, extended release · oralAPOTEXPrescription13 Jul 2023
OXCARBAZEPINE300MG/5MLsuspension · oralHETERO LABS LTD IIIPrescription20 Oct 2023
OXCARBAZEPINE300MG/5MLsuspension · oralKANCHAN HLTHCAREPrescription14 Feb 2024
OXCARBAZEPINE150MG; 300MG; 600MGtablet, extended release · oralAJANTA PHARMA LTDPrescription22 Feb 2024
OXCARBAZEPINE300MG/5MLsuspension · oralBIOCON PHARMAPrescription1 Mar 2024
OXCARBAZEPINE150MG; 300MG; 600MGtablet · oralRUBICON RESEARCHPrescription5 Mar 2024
OXCARBAZEPINE300MG/5MLsuspension · oralALKEM LABS LTDPrescription18 Mar 2024
OXCARBAZEPINE150MG; 300MG; 600MGtablet, extended release · oralRICONPHARMA LLCPrescription22 Nov 2024
OXCARBAZEPINE300MG/5MLsuspension · oralMACLEODS PHARMSPrescription11 Jul 2025

10 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-OXCARBAZEPINE02284294150 MGTABLET · ORALAPOTEX INC
APO-OXCARBAZEPINE02284308300 MGTABLET · ORALAPOTEX INC
APO-OXCARBAZEPINE02284316600 MGTABLET · ORALAPOTEX INC
JAMP OXCARBAZEPINE02560593150 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP OXCARBAZEPINE02560607300 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP OXCARBAZEPINE02560615600 MGTABLET · ORALJAMP PHARMA CORPORATION
TRILEPTAL 300 MG02242068300 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC
TRILEPTAL 600 MG02242069600 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC
TRILEPTAL ORAL SUSPENSION0224467360 MG / MLSUSPENSION · ORALNOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOXCARBAZEPINE 150 MG TABLET$0.10623per EA23 Sep 2026
US NADACOXCARBAZEPINE 300 MG TABLET$0.16669per EA23 Sep 2026
US NADACOXCARBAZEPINE 300 MG/5 ML SUSP$0.11023per ML23 Sep 2026
US NADACOXCARBAZEPINE 600 MG TABLET$0.31696per EA23 Sep 2026
US NADACOXCARBAZEPINE ER 150 MG TABLET$3.49768per EA23 Sep 2026
US NADACOXCARBAZEPINE ER 300 MG TABLET$4.73052per EA23 Sep 2026
US NADACOXCARBAZEPINE ER 600 MG TABLET$9.5783per EA23 Sep 2026
US NADACTRILEPTAL 150 MG TABLET$5.72156per EA7 Jan 2026
US NADACTRILEPTAL 300 MG TABLET$10.45435per EA23 Sep 2026
US NADACTRILEPTAL 300 MG/5 ML SUSP$1.93077per ML23 Sep 2026
US NADACTRILEPTAL 600 MG TABLET$19.33273per EA23 Sep 2026
NHS Drug TariffOxcarbazepine 150mg tablets£22.0550 tablet1 Oct 2026
NHS Drug TariffOxcarbazepine 300mg tablets£6.2350 tablet1 Oct 2026
NHS Drug TariffOxcarbazepine 600mg tablets£35.7950 tablet1 Oct 2026
NHS Drug TariffOxcarbazepine 60mg/ml oral suspension sugar free£48.96250 ml1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 23 Sep 2025 TRILEPTAL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Sep 2025 TRILEPTAL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Dec 2018 OXTELLAR XR — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for oxcarbazepine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.