Regulatory PathRegulatory requirements compared

Active substance

Meclizine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ANTIVERT50MG; 25MG; 12.5MGtablet · oralCASPER PHARMA LLCPrescription14 Feb 1957
ANTIVERT25MGtablet, chewable · oralCASPER PHARMA LLCPrescription14 Feb 1957
MECLIZINE HYDROCHLORIDE25MGtablet · oralQUAGENPrescription19 Mar 1975
MECLIZINE HYDROCHLORIDE12.5MGtablet · oralSANDOZPrescription3 Feb 1976
MECLIZINE HYDROCHLORIDE25MG; 12.5MGtablet · oralSENORES PHARMSPrescription3 Jun 1981
MECLIZINE HYDROCHLORIDE12.5MG; 25MGtablet · oralJUBILANT CADISTAPrescription4 Jun 2010
MECLIZINE HYDROCHLORIDE12.5MG; 25MG; 50MGtablet · oralAMNEAL PHARMSPrescription23 Feb 2011
MECLIZINE HYDROCHLORIDE12.5MG; 25MGtablet · oralEPIC PHARMA LLCPrescription13 Apr 2012
MECLIZINE HYDROCHLORIDE12.5MG; 25MG; 50MGtablet · oralAUROBINDO PHARMA USAPrescription17 Sep 2012
MECLIZINE HYDROCHLORIDE50MGtablet · oralHERITAGEPrescription22 Feb 2019
MECLIZINE HYDROCHLORIDE12.5MG; 25MGtablet · oralZYDUS LIFESCIENCESPrescription23 Jun 2020
MECLIZINE HYDROCHLORIDE12.5MG; 25MG; 50MGtablet · oralCHARTWELL RXPrescription11 Aug 2022
MECLIZINE HYDROCHLORIDE25MG; 12.5MGtablet · oralANI PHARMSDiscontinued1 Dec 1975
MECLIZINE HYDROCHLORIDE12.5MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued5 Dec 1975
MECLIZINE HYDROCHLORIDE25MGtablet, chewable · oralIVAX SUB TEVA PHARMSDiscontinued4 Oct 1976
MECLIZINE HYDROCHLORIDE12.5MGtablet · oralANI PHARMSDiscontinued11 Nov 1976
MECLIZINE HYDROCHLORIDE12.5MGtablet · oralABC HOLDINGDiscontinued7 Feb 1977
MECLIZINE HYDROCHLORIDE25MGtablet · oralABC HOLDINGDiscontinued15 Feb 1977
MECLIZINE HYDROCHLORIDE25MGtablet · oralKV PHARMDiscontinued3 Jun 1977
MECLIZINE HYDROCHLORIDE12.5MGtablet · oralKV PHARMDiscontinued8 Jun 1977
MECLIZINE HYDROCHLORIDE25MGtablet · oralANI PHARMSDiscontinued6 Jul 1977
MECLIZINE HYDROCHLORIDE25MGtablet · oralANABOLICDiscontinued31 May 1978
MECLIZINE HYDROCHLORIDE25MGtablet · oralBUNDYDiscontinued12 Jul 1978
MECLIZINE HYDROCHLORIDE25MGtablet, chewable · oralNEXGEN PHARMA INCDiscontinued14 Sep 1978
MECLIZINE HYDROCHLORIDE25MGtablet · oralVANGARDDiscontinued4 Jan 1982

15 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMECLIZINE 12.5 MG CAPLET$0.03127per EA23 Sep 2026
US NADACMECLIZINE 12.5 MG TABLET$0.04419per EA23 Sep 2026
US NADACMECLIZINE 12.5 MG TABLET$0.03127per EA23 Sep 2026
US NADACMECLIZINE 25 MG TABLET$0.07568per EA23 Sep 2026
US NADACMECLIZINE 25 MG TABLET$0.12808per EA23 Sep 2026
US NADACMECLIZINE 25 MG TABLET CHEW$0.03334per EA23 Sep 2026
US NADACMECLIZINE 50 MG TABLET$2.48424per EA7 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 28 Jun 2019 ANTIVERT — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for meclizine →

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.