Regulatory PathRegulatory requirements compared

Active substance

Valproic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DEPAKINE 200MG TABS200 mgGastro-resistant tablet · Oral use40 BlisterSAR 18.45NCE · Prescriptionsanofi-aventis FRANCEValid
DEPAKINE 200MG-ML SOLU.200 mg/mlOral solution · Oral use1 BottleSAR 16.35NCE · Prescriptionsanofi-aventis FRANCEValid
DEPAKINE 400MG-4ML Powder for injection100 mg/mlPowder and solvent for solution for injection · Intravenous use4 VialSAR 128.35NCE · PrescriptionSanofi Aventis FranceValid
DEPAKINE 500MG TABS500 mgGastro-resistant tablet · Oral use40 BlisterSAR 32.20NCE · Prescriptionsanofi-aventis FRANCEValid
DEPAKINE 57.64MG-ML SYRUP57.64 mg/mlSyrup · Oral use1 BottleSAR 20.85NCE · Prescriptionsanofi-aventisValid
DEPAKINE CHRONO 500MG TABS500 mgProlonged-release film-coated tablet · Oral use30 BottleSAR 51.85Generic · PrescriptionSanofi Aventis FranceValid
Sodium Valproate100 mg/mlSolution for injection/infusion · Intravenous use5 VialSAR 160.45Generic · PrescriptionSeacross Pharmaceuticals LtdValid
VALOPRA 200 MG-ML SOLUTION200 mg/mlSolution · Oral use1 BottleSAR 11.45Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
VALOPRA 57.64 MG-ML SYRUP57.64 mg/mlSyrup · Oral use1 BottleSAR 11.25Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
VALPOHARDT 100 mg/ml solution for injection or infusion100 mg/mlSolution for injection/infusion · Intravenous use5 AmpouleSAR 246.10Generic · PrescriptionWOCKHARDT UK LIMITEDValid
Votellaz500 mgProlonged-release tablet · Oral use30 BlisterSAR 46.65Generic · PrescriptionAurobindo Pharma LimitedValid
DEPAKINE 200MG TABS200 mgGastro-resistant tablet · Oral use40 BlisterSAR 21.70NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
DEPAKINE 200MG-ML SOLU.200 mg/mlOral solution · Oral use1 BottleSAR 16.35NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
DEPAKINE 400MG-4ML Powder for injection100 mg/mlPowder and solvent for solution for injection · Intravenous use4 VialSAR 195.00NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
DEPAKINE 500MG TABS500 mgGastro-resistant tablet · Oral use40 BlisterSAR 37.90NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
DEPAKINE 57.64MG-ML SYRUP40 mg/mlSyrup · Oral use1 BottleSAR 20.85NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
DEPAKINE CHRONO 500MG TABS500 mgProlonged-release film-coated tablet · Oral use30 BlisterSAR 61.00Generic · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
EPIVAL 200MG\5ML SYRUP40 mg/mlSyrup · Oral use1 BottleSAR 7.50Generic · PrescriptionUNITED PHARMACEUTICAL CO.Withdrawn by MAH · Not Marketed
VALIREC 200 MG-5 ML SYRUP40 mgSyrup · Oral use1 BottleSAR 13.10Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
VALOPIN 200 MG E-C TABLETS200 mgGastro-resistant tablet · Oral use40 BlisterSAR 15.20Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
VALOPIN 200MG\5ML SYRUP40 mg/mlSyrup · Oral use1 BottleSAR 8.35Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
VALOPIN 500 MG E-C TABLETS500 mgGastro-resistant tablet · Oral use30 BlisterSAR 21.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ACUTE MANIA; ANXIETY DISORDERS; BIPOLAR I DISORDER MAINTENANCE; BIPOLAR II DISORDER; DIABETIC NEUROPATHY; DRAVET SYNDROME; JUVENILE MYOCLONIC SEIZURES; LENNOX GASTAUT SYNDROME AND TONIC OR ATONIC SEIZURES; MIGRAINE/ HEADACHE; MYOCLONIC SEIZURES

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

ProductStrengthForm · routeApplicantStatusFirst approved
DEPAKOTEEQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACID; EQ 125MG VALPROIC ACIDtablet, delayed release · oralABBVIEPrescription10 Mar 1983
DEPAKOTEEQ 125MG VALPROIC ACIDcapsule, delayed rel pellets · oralABBVIEPrescription12 Sep 1989
VALPROIC ACID250MGcapsule · oralCATALENTPrescription29 Oct 1991
VALPROIC ACID250MG/5MLsyrup · oralANI PHARMSPrescription25 Aug 1992
VALPROIC ACID250MGcapsule · oralBIONPHARMAPrescription29 Jun 1993
DEPAKOTE EREQ 500MG VALPROIC ACID; EQ 250MG VALPROIC ACIDtablet, extended release · oralABBVIEPrescription4 Aug 2000
VALPROIC ACID250MG/5MLsyrup · oralPHARM ASSOCPrescription15 Dec 2000
VALPROIC ACID250MG/5MLsyrup · oralCHARTWELL RXPrescription22 Dec 2000
VALPROATE SODIUMEQ 100MG BASE/MLinjectable · injectionSAGENTPrescription14 Nov 2002
DEPAKOTE ER250MG; 500MGtablet, extended release · oralABBOTTPrescription20 Dec 2002
VALPROATE SODIUMEQ 100MG BASE/MLinjectable · injectionFRESENIUS KABI USAPrescription26 Jun 2003
DEPAKOTE ER250MG; 500MGtablet, extended release · oralABBVIE INCPrescription24 Mar 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralUPSHER SMITH LABSPrescription29 Jul 2008
DIVALPROEX SODIUMEQ 500MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 125MG VALPROIC ACIDtablet, delayed release · oralINVATECHPrescription29 Jul 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralSUN PHARM INDSPrescription29 Jul 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralDR REDDYS LABS LTDPrescription29 Jul 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralCHARTWELL RXPrescription31 Jul 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralORBION PHARMSPrescription25 Nov 2008
DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDcapsule, delayed rel pellets · oralDR REDDYS LABS LTDPrescription23 Jan 2009
DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDcapsule, delayed rel pellets · oralZYDUS PHARMS USA INCPrescription27 Jan 2009
DIVALPROEX SODIUMEQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, extended release · oralMYLANPrescription29 Jan 2009
DIVALPROEX SODIUMEQ 500MG VALPROIC ACID; EQ 250MG VALPROIC ACIDtablet, extended release · oralSCIEGEN PHARMSPrescription10 Feb 2009
DIVALPROEX SODIUMEQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, extended release · oralZYDUS PHARMS USA INCPrescription27 Feb 2009
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralZYDUS PHARMS USA INCPrescription5 Mar 2009
DIVALPROEX SODIUMEQ 125MG VALPROIC ACID; EQ 250MG VALPROIC ACID; EQ 500MG VALPROIC ACIDtablet, delayed release · oralPRINSTON INCPrescription30 Nov 2009

42 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-DIVALPROEX02239698125 MGTABLET (DELAYED-RELEASE) · ORALAPOTEX INC
APO-DIVALPROEX02239699250 MGTABLET (DELAYED-RELEASE) · ORALAPOTEX INC
APO-DIVALPROEX02239700500 MGTABLET (DELAYED-RELEASE) · ORALAPOTEX INC
APO-VALPROIC ACID02238048250 MGCAPSULE · ORALAPOTEX INC
DEPAKENE00443832250 MG / 5 MLSOLUTION · ORALBGP PHARMA ULC
EPIVAL00596418125 MGTABLET (DELAYED-RELEASE) · ORALBGP PHARMA ULC
EPIVAL00596426250 MGTABLET (DELAYED-RELEASE) · ORALBGP PHARMA ULC
EPIVAL00596434500 MGTABLET (DELAYED-RELEASE) · ORALBGP PHARMA ULC
JAMP DIVALPROEX02551152250 MGTABLET (DELAYED-RELEASE) · ORALJAMP PHARMA CORPORATION
JAMP DIVALPROEX02551160500 MGTABLET (DELAYED-RELEASE) · ORALJAMP PHARMA CORPORATION
JAMP VALPROIC ACID ORAL SOLUTION02532441250 MG / 5 MLSOLUTION · ORALJAMP PHARMA CORPORATION
MYLAN-DIVALPROEX02458926125 MGTABLET (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-DIVALPROEX02458934250 MGTABLET (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-DIVALPROEX02459019500 MGTABLET (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
ODAN-VALPROIC ACID02549190250 MG / 5 MLSOLUTION · ORALODAN LABORATORIESLTD
PMS-VALPROIC ACID02230768250 MGCAPSULE · ORALPHARMASCIENCE INC
PMS-VALPROIC ACID02236807250 MG / 5 MLSOLUTION · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDEPAKOTE DR 125 MG SPRINKLE CP$1.96951per EA23 Sep 2026
US NADACDEPAKOTE DR 125 MG TABLET$2.05517per EA23 Sep 2026
US NADACDEPAKOTE DR 250 MG TABLET$4.0456per EA23 Sep 2026
US NADACDEPAKOTE DR 500 MG TABLET$7.45557per EA23 Sep 2026
US NADACDEPAKOTE ER 250 MG TABLET$3.68703per EA23 Sep 2026
US NADACDEPAKOTE ER 500 MG TABLET$6.49213per EA23 Sep 2026
US NADACDIVALPROEX DR 125 MG CAP SPRNK$0.20079per EA23 Sep 2026
US NADACDIVALPROEX SOD DR 125 MG TAB$0.05494per EA23 Sep 2026
US NADACDIVALPROEX SOD DR 250 MG TAB$0.08564per EA23 Sep 2026
US NADACDIVALPROEX SOD DR 500 MG TAB$0.16081per EA23 Sep 2026
US NADACDIVALPROEX SOD ER 250 MG TAB$0.12984per EA23 Sep 2026
US NADACDIVALPROEX SOD ER 500 MG TAB$0.19434per EA23 Sep 2026
NHS Drug TariffSodium valproate 100mg modified-release granules sachets sugar free£30.0030 sachet1 Oct 2026
NHS Drug TariffSodium valproate 100mg tablets£1.6830 tablet1 Oct 2026
NHS Drug TariffSodium valproate 150mg modified-release capsules£2.7630 capsule1 Oct 2026
NHS Drug TariffSodium valproate 1g modified-release granules sachets sugar free£12.3030 sachet1 Oct 2026
NHS Drug TariffSodium valproate 200mg gastro-resistant tablets£1.9930 tablet1 Oct 2026
NHS Drug TariffSodium valproate 200mg modified-release tablets£3.5030 tablet1 Oct 2026
NHS Drug TariffSodium valproate 200mg/5ml oral solution£9.33300 ml1 Oct 2026
NHS Drug TariffSodium valproate 200mg/5ml oral solution sugar free£12.55300 ml1 Oct 2026
NHS Drug TariffSodium valproate 250mg modified-release granules sachets sugar free£30.0030 sachet1 Oct 2026
NHS Drug TariffSodium valproate 300mg modified-release capsules£4.5630 capsule1 Oct 2026
NHS Drug TariffSodium valproate 300mg modified-release tablets£5.2430 tablet1 Oct 2026
NHS Drug TariffSodium valproate 300mg/3ml solution for injection ampoules£35.005 ampoule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 5.1.1. Antiseizure medicines · core
    Epilepsy or seizures
    Oral > Liquid: 200 mg per 5 mL | Oral > Solid: 200 mg tablet (enteric-coated); 500 mg tablet (enteric-coated); 100 mg tablet (crushable)
  • 5.1.1. Antiseizure medicines · complementary
    Status epilepticus
    Parenteral > General injections > IV: 100 mg per mL in 4 mL ampoule; 100 mg per mL in 10 mL ampoule; 100 mg per mL in 3 mL ampoule
  • 24.2.2. Medicines for bipolar disorders · core
    Bipolar or related disorders
    Oral > Solid: 200 mg tablet (enteric-coated); 500 mg tablet (enteric-coated)

Safety signals and safety-related labeling changes

  • US FDA 31 Mar 2026 DEPAKOTE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 31 Mar 2026 DEPAKOTE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 31 Mar 2026 DEPAKOTE ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 31 Mar 2026 STAVZOR — 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 19 May 2020 DEPAKENE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 19 May 2020 DEPAKENE — 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

All safety entries for valproic acid →

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.