Regulatory PathRegulatory requirements compared

Active substance

Diazepam

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DIAPAM 10MG/2ML SOL. FOR INJ./INF5 mg/mlSolution for injection/infusion · Intramuscular and intravenous use10 VialSAR 23.85Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
VALIUM AMP 10MG-2ML5 mg/mlSolution for injection · Intravenous use10 AmpouleSAR 23.85Generic · PrescriptionAtnahs Pharma UK LimitedValid
VALIUM TAB 10 MG10 mgTablet · Oral use25 BlisterSAR 24.05NCE · PrescriptionROCHEValid
VALIUM TAB 2 MG2 mgTablet · Oral use30 BlisterSAR 11.00Generic · PrescriptionROCHEValid
VALIUM TAB 5MG5 mgTablet · Oral use25 BlisterSAR 16.80Generic · PrescriptionAtnahs Pharma UK LimitedValid
DIAZEPAM TAB 2 MG2 mgTablet · Oral use30 BlisterSAR 5.40Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
DIAZEPAM TAB 5 MG5 mgTablet · Oral use30 BlisterSAR 7.85Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
STESOLID 5MG RECTAL TUBE5 mgOintment · Rectal use4 TubeSAR 26.20Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID INJ 10 MG-2 ML5 mg/mlSolution · Intravenous use5 AmpouleSAR 10.90NCE · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID RECTAL TUBE 10 MG10 mgOintment · Rectal use4 TubeSAR 32.25NCE · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID SUPP 5 MG5 mgSuppository · Rectal use5 BlisterSAR 4.80Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID SUPP. 10 MG10 mgSuppository · Rectal use5 BlisterSAR 9.55Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID SYRUP 0.4 MG-ML0.4 mg/mlSyrup · Oral use1 BottleSAR 8.65NCE · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID TAB 2 MG2 mgTablet · Oral use25 BlisterSAR 4.70Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
STESOLID TAB. 5 MG5 mgTablet · Oral use25 BlisterSAR 9.10Generic · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
VALINIL 22 mgTablet · Oral use30 BlisterSAR 4.75Generic · PrescriptionTHE NILE COMPANY FOR PHARMACEUTICALS AND CHEMICAL IND.Withdrawn by MAH · Not Marketed
VALINIL 55 mgTablet · Oral use30 BlisterSAR 5.50Generic · PrescriptionTHE NILE COMPANY FOR PHARMACEUTICALS AND CHEMICAL IND.Invalid · Not Marketed
VALIUM SYRUP 2 MG-5 ML0.4 mg/mlSyrup · Oral use1 BottleSAR 16.60Generic · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE MANIA; ANESTHESIA; ANXIETY DISORDERS; BIPOLAR II DISORDER; HUNTINGTON'S DISEASE-TICS; MULTIPLE SCLEROSIS; SCHIZOPHRENIA; SPASTICITY; STATUS EPILEPTICUS; VERTIGO - MOTION SICKNESS; VERTIGO -BENIGN PAROXYSMAL POSITIONAL VERTIGO AND ACUTE VESTIBULAR NEURONITIS OR LABYRINTHITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
VALIUM2MG; 5MG; 10MGtablet · oralWAYLIS THERAPPrescription15 Nov 1963
DIAZEPAM10MG; 2MG; 5MGtablet · oralMYLANPrescription4 Sep 1985
DIAZEPAM50MG/10ML (5MG/ML)injectable · injectionHIKMA PHARMSPrescription16 Dec 1985
DIAZEPAM10MG/2ML (5MG/ML)injectable · injectionHIKMA PHARMSPrescription16 Dec 1985
DIAZEPAM10MG; 2MG; 5MGtablet · oralNUVO PHARMPrescription25 Feb 1986
DIAZEPAM2MGtablet · oralIVAX SUB TEVA PHARMSPrescription10 Dec 1986
DIAZEPAM5MGtablet · oralIVAX SUB TEVA PHARMSPrescription10 Dec 1986
DIAZEPAM10MGtablet · oralIVAX SUB TEVA PHARMSPrescription10 Dec 1986
DIAZEPAM2MGtablet · oralDR REDDYS LABS SAPrescription3 Feb 1987
DIAZEPAM5MGtablet · oralDR REDDYS LABS SAPrescription3 Feb 1987
DIAZEPAM10MGtablet · oralDR REDDYS LABS SAPrescription3 Feb 1987
DIAZEPAM5MG/5MLsolution · oralHIKMA PHARMSPrescription3 Apr 1987
DIAZEPAM INTENSOL5MG/MLconcentrate · oralHIKMA PHARMSPrescription3 Apr 1987
DIAZEPAM50MG/10ML (5MG/ML)injectable · injectionHOSPIRAPrescription13 Oct 1987
DIAZEPAM10MG/2ML (5MG/ML)injectable · injectionHOSPIRAPrescription20 Dec 1988
DIASTAT2.5MG/0.5ML (5MG/ML)gel · rectalBAUSCHPrescription29 Jul 1997
DIASTAT ACUDIAL20MG/4ML (5MG/ML); 10MG/2ML (5MG/ML)gel · rectalBAUSCHPrescription29 Jul 1997
DIAZEPAM5MG/MLconcentrate · oralCHARTWELL MOLECULARPrescription14 Apr 2014
DIAZEPAM5MG/5MLsolution · oralCHARTWELL MOLECULARPrescription24 Jun 2016
DIAZEPAM10MG/2ML (5MG/ML)injectable · injectionREGCON HOLDINGSPrescription18 Mar 2019
DIAZEPAM50MG/10ML (5MG/ML)injectable · injectionREGCON HOLDINGSPrescription26 Dec 2019
VALTOCO5MG/SPRAY; 7.5MG/SPRAY; 10MG/SPRAYspray · nasalNEURELIS INCPrescription10 Jan 2020
DIAZEPAM10MG/2ML (5MG/ML)injectable · injectionFRESENIUS KABI USAPrescription10 Nov 2022
DIAZEPAM10MG/2ML (5MG/ML); 20MG/4ML (5MG/ML)gel · rectalNOVEL LABS INCPrescription30 May 2023
DIAZEPAM2MG; 5MG; 10MGtablet · oralAUROBINDO PHARMA LTDPrescription14 Dec 2023

75 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DIASTAT022381625 MG / 1 MLGEL · RECTALBAUSCH HEALTH, CANADA INC.
DIASTAT0251907010 MG / 2 MLGEL · RECTALBAUSCH HEALTH, CANADA INC.
DIASTAT0251908915 MG / 3 MLGEL · RECTALBAUSCH HEALTH, CANADA INC.
DIAZEPAM003621585 MGTABLET · ORALAA PHARMA INC
DIAZEPAM004053292 MGTABLET · ORALAA PHARMA INC
DIAZEPAM0040533710 MGTABLET · ORALAA PHARMA INC
DIAZEPAM INJECTION USP003997285 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
VALIUM000132855 MGTABLET · ORALSEARCHLIGHT PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDIAZEPAM 10 MG RECTAL GEL$208.71283per EA23 Sep 2026
US NADACDIAZEPAM 10 MG RECTAL GEL (2PK)$208.71283per EA23 Sep 2026
US NADACDIAZEPAM 10 MG RECTAL GEL SYRG$208.71283per EA23 Sep 2026
US NADACDIAZEPAM 10 MG TABLET$0.02828per EA23 Sep 2026
US NADACDIAZEPAM 2 MG TABLET$0.02123per EA23 Sep 2026
US NADACDIAZEPAM 20 MG RECTAL GEL$171.53691per EA23 Sep 2026
US NADACDIAZEPAM 20 MG RECTAL GEL (2PK)$171.53691per EA23 Sep 2026
US NADACDIAZEPAM 20 MG RECTAL GEL SYRG$171.53691per EA23 Sep 2026
US NADACDIAZEPAM 25 MG/5 ML ORAL CONC$1.06202per ML23 Sep 2026
US NADACDIAZEPAM 5 MG TABLET$0.02761per EA23 Sep 2026
US NADACDIAZEPAM 5 MG/5 ML SOLUTION$0.10708per ML23 Sep 2026
US NADACDIAZEPAM 5 MG/ML ORAL CONC$1.06202per ML23 Sep 2026
NHS Drug TariffDiazepam 10mg tablets£0.8428 tablet1 Oct 2026
NHS Drug TariffDiazepam 10mg/2.5ml rectal solution tube£8.785 tube1 Oct 2026
NHS Drug TariffDiazepam 10mg/2ml solution for injection ampoules£40.3010 ampoule1 Oct 2026
NHS Drug TariffDiazepam 2mg tablets£0.7328 tablet1 Oct 2026
NHS Drug TariffDiazepam 5mg tablets£0.7428 tablet1 Oct 2026
NHS Drug TariffDiazepam 5mg/2.5ml rectal solution tube£5.855 tube1 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
    Therapeutic equivalent to lorazepam for Status epilepticus; Status epilepticus
    Local > Rectal > Gel: 5 mg per mL in 0.5 mL rectal delivery system; 5 mg per mL in 2 mL rectal delivery system; 5 mg per mL in 4 mL rectal delivery system | Local > Rectal > Solution: 2 mg per mL in 1.25 mL rectal tube; 2 mg per mL in 2.5 mL rectal tube; 4 mg per mL in 2.5 mL rectal tube
  • 2.3. Medicines for other common symptoms in palliative care · core
    Palliative care
    Oral > Liquid: 2 mg per 5 mL | Local > Rectal > Gel: 5 mg per mL in 0.5 mL rectal delivery system; 5 mg per mL in 2 mL rectal delivery system; 5 mg per mL in 4 mL rectal delivery system | Local > Rectal > Solution: 2 mg per mL in 1.25 mL rectal tube; 2 mg per mL in 2.5 mL rectal tube; 4 mg per mL in 2.5 mL rectal tube | Parenteral > General injections > unspecified: 5 mg per mL (EML) | Oral > Solid > tablet: 5 mg (scored); 10 mg (scored); 2 mg (scored) (EMLc)
  • 24.3. Medicines for anxiety disorders · core
    Anxiety
    Oral > Solid: 5 mg (scored); 2 mg (scored)

Safety signals and safety-related labeling changes

All safety entries for diazepam →

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.