Regulatory PathRegulatory requirements compared

Active substance

Tizanidine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RELEZIN 2 MG TABLET2 mgTablet · Oral use30 BlisterSAR 14.75Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
RELEZIN 4 MG TABLET4 mgTablet · Oral use30 BlisterSAR 24.20Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
SIRDALUD 2MG TAB2 mgTablet · Oral use30 BlisterSAR 18.75NCE · PrescriptionSandoz PharmaceuticalsValid
SIRDALUD 4MG TAB4 mgTablet · Oral use30 BlisterSAR 30.70NCE · PrescriptionSandoz PharmaceuticalsValid
TILAX 2 MG TABLET2 mgTablet · Oral use30 BlisterSAR 17.80Generic · PrescriptionRIYADH PHARMAValid
TILAX 4 MG TABLET4 mgTablet · Oral use30 BlisterSAR 29.15Generic · PrescriptionRIYADH PHARMAValid
SIRDALUD 2MG TAB2 mgTablet · Oral use30 BlisterSAR 23.45NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
SIRDALUD 4MG TAB4 mgTablet · Oral use30 BlisterSAR 38.40NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

LOW BACK PAIN; MULTIPLE SCLEROSIS; SPASTICITY

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZANAFLEXEQ 4MG BASEtablet · oralLEGACYPrescription27 Nov 1996
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralDR REDDYS LABS INCPrescription3 Jul 2002
ZANAFLEXEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralLEGACYPrescription29 Aug 2002
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralEPIC PHARMA LLCPrescription11 Oct 2002
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralRISINGPrescription28 Mar 2003
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralSUN PHARM INDS INCPrescription29 Sep 2003
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralTP ANDA HOLDINGSPrescription20 Oct 2003
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralAUROBINDO PHARMA USAPrescription16 Dec 2003
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralAPOTEXPrescription16 Jan 2004
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralAPOTEX INCPrescription3 Feb 2012
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralUNICHEM LABS LTDPrescription28 Nov 2012
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralZYDUS PHARMSPrescription3 Mar 2017
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralJUBILANT GENERICSPrescription4 Aug 2017
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralCADILAPrescription9 Mar 2018
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralALKEM LABS LTDPrescription25 Jan 2019
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralINGENUS PHARMS LLCPrescription12 Mar 2019
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralCADILA PHARMS LTDPrescription26 Mar 2019
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralALKEM LABS LTDPrescription27 Mar 2019
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralALEMBICPrescription13 Jan 2020
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASEcapsule · oralAUROBINDO PHARMA LTDPrescription24 Mar 2020
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASE; EQ 6MG BASE; EQ 8MG BASEcapsule · oralRUBICON RESEARCHPrescription27 May 2020
TIZANIDINE HYDROCHLORIDEEQ 4MG BASE; EQ 6MG BASEcapsule · oralSENORES PHARMSPrescription13 May 2024
TIZANIDINE HYDROCHLORIDEEQ 2MG BASE; EQ 4MG BASEtablet · oralRISINGPrescription7 Aug 2024
ONTRALFYEQ 2MG BASE/5MLsolution · oralFIDELITY BIOPHARMAPrescription12 Dec 2024
ZANAFLEXEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLEGACYDiscontinued27 Nov 1996

8 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-TIZANIDINE022598934 MGTABLET · ORALAPOTEX INC
MINT-TIZANIDINE025367654 MGTABLET · ORALMINT PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTIZANIDINE HCL 2 MG CAPSULE$0.09015per EA23 Sep 2026
US NADACTIZANIDINE HCL 2 MG TABLET$0.0317per EA23 Sep 2026
US NADACTIZANIDINE HCL 4 MG CAPSULE$0.09672per EA23 Sep 2026
US NADACTIZANIDINE HCL 4 MG TABLET$0.03306per EA23 Sep 2026
US NADACTIZANIDINE HCL 6 MG CAPSULE$0.14053per EA23 Sep 2026
NHS Drug TariffTizanidine 2mg tablets£4.76120 tablet1 Oct 2026
NHS Drug TariffTizanidine 4mg tablets£7.88120 tablet1 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 22 Nov 2024 ZANAFLEX — 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 22 Nov 2024 ZANAFLEX — 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 tizanidine →

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.