Regulatory PathRegulatory requirements compared

Active substance

Haloperidol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HALDOL 2MG-ML DROPS2 mg/mlOral drops · Oral use1 BottleSAR 11.45NCE · PrescriptionJANSSEN PHARMACEUTICA N.VValid
HALDOL 5MG TABLET5 mgTablet · Oral use25 BlisterSAR 19.75Generic · PrescriptionJANSSEN-CILAGValid
HALDOL 5MG-ML AMP5 mg/mlSolution for injection · Parenteral use5 AmpouleSAR 23.15NCE · PrescriptionJANSSEN PHARMACEUTICA N.VValid
HALDOL DECANOAS INJ 100MG-ML100 mg/mlSolution for injection · Intramuscular use1 AmpouleSAR 41.35NCE · PrescriptionJANSSEN PHARMACEUTICA N.VValid
HALDOL DECANOAS INJ 50MG50 mg/mlSolution for injection · Intramuscular use1 AmpouleSAR 21.85NCE · PrescriptionJANSSEN PHARMACEUTICA N.VValid
SERENACE10 mgTablet · Oral use50 BlisterSAR 57.35NCE · PrescriptionG.D.SEARLEWithdrawn by MAH · Not Marketed
SERENACE1.5 mgTablet · Oral use50 BlisterSAR 16.45NCE · PrescriptionG.D.SEARLEWithdrawn by MAH · Not Marketed
SERENACE5 mgTablet · Oral use50 BlisterSAR 43.00NCE · PrescriptionG.D.SEARLEWithdrawn by MAH · Not Marketed
SYLADOR 0.5MG TAB0.5 mgTablet · Oral use60 BlisterSAR 14.05Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
SYLADOR INJ 5MG-ML5 mg/mlSolution · Parenteral use5 AmpouleSAR 15.50Generic · PrescriptionALPHARMA APSInvalid · Not Marketed
SYLADOR TAB 2 MG.2 mgTablet · Oral use60 BlisterSAR 23.80Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
SYLADOR TAB. 5 MG.5 mgTablet · Oral use60 BlisterSAR 56.70Generic · PrescriptionALPHARMA APSWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE MANIA; ALZHEIMER / DEMENTIA; ANESTHESIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; HUNTINGTON'S DISEASE; POSTOPERATIVE NAUSEA AND VOMITING

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

ProductStrengthForm · routeApplicantStatusFirst approved
HALOPERIDOL2MG; 1MG; 5MG; 0.5MGtablet · oralMYLANPrescription10 Jun 1986
HALOPERIDOL0.5MGtablet · oralSANDOZPrescription17 Nov 1986
HALOPERIDOL1MGtablet · oralSANDOZPrescription17 Nov 1986
HALOPERIDOL5MG; 0.5MG; 1MGtablet · oralCHARTWELL RXPrescription17 Nov 1986
HALOPERIDOL2MG; 5MG; 10MG; 0.5MG; 1MG; 20MGtablet · oralAIPING PHARM INCPrescription17 Feb 1987
HALOPERIDOL10MG; 0.5MG; 1MG; 2MG; 5MG; 20MGtablet · oralSCIEGEN PHARMSPrescription7 Jan 1988
HALOPERIDOL10MGtablet · oralCHARTWELL RXPrescription11 Mar 1988
HALOPERIDOL20MGtablet · oralCHARTWELL RXPrescription11 Mar 1988
HALOPERIDOLEQ 2MG BASE/MLconcentrate · oralPHARM ASSOCPrescription26 Feb 1993
HALOPERIDOLEQ 2MG BASE/MLconcentrate · oralLANNETT CO INCPrescription28 Sep 1993
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionFRESENIUS KABI USAPrescription19 Dec 1997
HALOPERIDOL DECANOATEEQ 100MG BASE/MLinjectable · injectionHIKMA PHARMSPrescription28 Sep 1998
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionMYLAN LABS LTDPrescription28 Feb 2000
HALOPERIDOLEQ 5MG BASE/MLinjectable · injectionFRESENIUS KABI USAPrescription9 Mar 2001
HALOPERIDOLEQ 5MG BASE/MLinjectable · injectionHIKMA PHARMSPrescription18 Jun 2001
HALOPERIDOL0.5MG; 1MG; 5MG; 10MG; 20MG; 2MGtablet · oralZYDUS PHARMS USAPrescription29 Nov 2007
HALOPERIDOLEQ 5MG BASE/MLinjectable · injectionMYLAN LABS LTDPrescription14 Sep 2009
HALOPERIDOLEQ 5MG BASE/MLinjectable · injectionSAGENT PHARMSPrescription2 Sep 2011
HALOPERIDOLEQ 5MG BASE/MLinjectable · injectionSAGENT PHARMSPrescription2 Sep 2011
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionGLANDPrescription12 May 2017
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionSOMERSET THERAPS LLCPrescription3 Jul 2018
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionZYDUS PHARMSPrescription22 Oct 2019
HALOPERIDOL0.5MG; 1MG; 2MG; 5MG; 10MG; 20MGtablet · oralAPPCOPrescription8 Jan 2020
HALOPERIDOL DECANOATEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionMEITHEALPrescription26 Jul 2021
HALOPERIDOL0.5MG; 1MG; 2MG; 5MG; 10MG; 20MGtablet · oralMSNPrescription18 Nov 2022

102 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HALOPERIDOL INJ 5MG/ML USP008086525 MG / MLLIQUID · INTRAMUSCULARSANDOZ CANADA INCORPORATED
HALOPERIDOL INJECTION023660105 MG / MLSOLUTION · INTRAMUSCULARJUNO PHARMA CANADA INC.
HALOPERIDOL INJECTION, USP024064115 MG / MLSOLUTION · INTRAMUSCULARFRESENIUS KABI CANADA LTD
HALOPERIDOL LA02130300100 MG / MLLIQUID · INTRAMUSCULARSANDOZ CANADA INCORPORATED
TEVA-HALOPERIDOL003636505 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-HALOPERIDOL003636692 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-HALOPERIDOL003636771 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-HALOPERIDOL003636850.5 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-HALOPERIDOL0071344910 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACHALOPERIDOL 0.5 MG TABLET$0.08568per EA30 Sep 2026
US NADACHALOPERIDOL 1 MG TABLET$0.11953per EA30 Sep 2026
US NADACHALOPERIDOL 10 MG TABLET$0.14643per EA30 Sep 2026
US NADACHALOPERIDOL 2 MG TABLET$0.16576per EA30 Sep 2026
US NADACHALOPERIDOL 20 MG TABLET$0.37115per EA30 Sep 2026
US NADACHALOPERIDOL 5 MG TABLET$0.18065per EA30 Sep 2026
US NADACHALOPERIDOL DEC 100 MG/ML AMP$33.92227per ML23 Sep 2026
US NADACHALOPERIDOL DEC 100 MG/ML VIAL$16.1395per ML7 Oct 2026
US NADACHALOPERIDOL DEC 100 MG/ML VIAL$7.5241per ML23 Sep 2026
US NADACHALOPERIDOL DEC 100 MG/ML VIAL$15.59807per ML23 Sep 2026
US NADACHALOPERIDOL DEC 50 MG/ML AMPUL$20.75247per ML23 Sep 2026
US NADACHALOPERIDOL DEC 50 MG/ML VIAL$6.57233per ML23 Sep 2026
NHS Drug TariffHaloperidol 1.5mg tablets£4.6528 tablet1 Oct 2026
NHS Drug TariffHaloperidol 10mg tablets£15.6428 tablet1 Oct 2026
NHS Drug TariffHaloperidol 10mg/5ml oral solution sugar free£4.45100 ml1 Oct 2026
NHS Drug TariffHaloperidol 200micrograms/ml oral solution sugar free£185.00100 ml1 Oct 2026
NHS Drug TariffHaloperidol 500microgram tablets£225.2828 tablet1 Oct 2026
NHS Drug TariffHaloperidol 5mg tablets£4.5528 tablet1 Oct 2026
NHS Drug TariffHaloperidol 5mg/1ml solution for injection ampoules£35.8310 ampoule1 Oct 2026
NHS Drug TariffHaloperidol 5mg/5ml oral solution sugar free£25.10100 ml1 Oct 2026
NHS Drug TariffHaloperidol decanoate 100mg/1ml solution for injection ampoules£25.265 ampoule1 Oct 2026
NHS Drug TariffHaloperidol decanoate 50mg/1ml solution for injection ampoules£19.065 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)

  • 2.3. Medicines for other common symptoms in palliative care · core
    Palliative care
    Oral > Liquid: 2 mg per mL | Oral > Solid: 0.5 mg; 2 mg; 5 mg | Parenteral > General injections > unspecified: 5 mg per mL in 1-mL ampoule
  • 24.1. Medicines for psychotic disorders · core (EML); complementary (EMLc)
    Schizophrenia or other primary psychotic disorders
    Parenteral > General injections > IM: 5 mg per mL in ampoule | Oral > Solid: 2 mg; 5 mg
  • 24.1. Medicines for psychotic disorders · core
    Therapeutic equivalent to fluphenazine for Schizophrenia or other primary psychotic disorders

Safety signals and safety-related labeling changes

All safety entries for haloperidol →

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.