Regulatory PathRegulatory requirements compared

Active substance

Ezetimibe

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
EZECHOL 10 mg tablet10 mgTablet · Oral use30 BlisterSAR 131.65Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
EZENTIA10 mgTablet · Oral use30 BlisterSAR 109.50Generic · PrescriptionALPHA PHARMA INDUSTRYValid
EZETROL 10 mg tablet10 mgTablet · Oral use28 BlisterSAR 159.80NCE · PrescriptionOrganon Pharma UK LimitedValid
Etimicol 1010 mgTablet · Oral use30 BlisterSAR 118.50Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
LIPIZET 10MG TABLET10 mgTablet · Oral use28 BlisterSAR 110.60Generic · PrescriptionLABORATORIOS CINFA SAValid
ZETEX 10 mg tablet10 mgTablet · Oral use30 BlisterSAR 146.30Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
Zavoxa10 mgTablet · Oral use30 BlisterSAR 118.50Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; DYSLIPIDEMIA; ISCHEMIC STROKE

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZETIA10MGtablet · oralORGANONPrescription25 Oct 2002
EZETIMIBE10MGtablet · oralGLENMARK PHARMS LTDPrescription26 Jun 2015
EZETIMIBE10MGtablet · oralSANDOZPrescription12 Jun 2017
EZETIMIBE10MGtablet · oralZYDUS PHARMSPrescription12 Jun 2017
EZETIMIBE10MGtablet · oralOHM LABS INCPrescription12 Jun 2017
EZETIMIBE10MGtablet · oralAMNEAL PHARMS COPrescription12 Jun 2017
EZETIMIBE10MGtablet · oralAUROBINDO PHARMAPrescription25 Aug 2017
EZETIMIBE10MGtablet · oralALKEM LABS LTDPrescription21 Dec 2017
EZETIMIBE10MGtablet · oralACCORD HLTHCAREPrescription26 Oct 2018
EZETIMIBE10MGtablet · oralSCIEGEN PHARMSPrescription23 Oct 2020
EZETIMIBE10MGtablet · oralHETERO LABS LTD IIIPrescription26 Jul 2022
EZETIMIBE10MGtablet · oralORIENT PHARMAPrescription13 Sep 2022
EZETIMIBE10MGtablet · oralTEVA PHARMS USADiscontinued12 Jun 2017
EZETIMIBE10MGtablet · oralWATSON LABS INCDiscontinued12 Jun 2017
EZETIMIBE10MGtablet · oralAPOTEXDiscontinued12 Jun 2017
EZETIMIBE10MGtablet · oralRISINGDiscontinued26 Apr 2019
EZETIMIBE10MGtablet · oralMACLEODS PHARMSDiscontinued29 Apr 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-EZETIMIBE0242561010 MGTABLET · ORALACCORD HEALTHCARE INC
AG-EZETIMIBE0247589810 MGTABLET · ORALANGITA PHARMA INC.
APO-EZETIMIBE0242782610 MGTABLET · ORALAPOTEX INC
AURO-EZETIMIBE0246928610 MGTABLET · ORALAURO PHARMA INC
BIO-EZETIMIBE0242521110 MGTABLET · ORALBIOMED PHARMA
EZETIMIBE0242254910 MGTABLET · ORALPRO DOC LIMITEE
EZETIMIBE0243130010 MGTABLET · ORALSANIS HEALTH INC
EZETIMIBE0247854410 MGTABLET · ORALLABORATOIRE RIVA INC.
EZETROL0224752110 MGTABLET · ORALORGANON CANADA INC.
JAMP-EZETIMIBE0242323510 MGTABLET · ORALJAMP PHARMA CORPORATION
M-EZETIMIBE0246743710 MGTABLET · ORALMANTRA PHARMA INC
MAR-EZETIMIBE0242266210 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-EZETIMIBE0242324310 MGTABLET · ORALMINT PHARMACEUTICALS INC
NRA-EZETIMIBE TABLETS0253642010 MGTABLET · ORALNORA PHARMA INC
PMS-EZETIMIBE0241640910 MGTABLET · ORALPHARMASCIENCE INC
SANDOZ EZETIMIBE0241677810 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SPC-EZETIMIBE0241954810 MGTABLET · ORALSUN PHARMA CANADA INC
TEVA-EZETIMIBE0235410110 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACEZETIMIBE 10 MG TABLET$0.06672per EA23 Sep 2026
US NADACZETIA 10 MG TABLET$13.93688per EA23 Sep 2026
NHS Drug TariffEzetimibe 10mg tablets£1.1828 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 9 Jan 2026 NEXLIZET — 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 28 Oct 2024 LIPTRUZET — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 26 Aug 2024 ROSZET — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 28 Mar 2024 VYTORIN — 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 21 Feb 2024 ZETIA — 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 ezetimibe →

Combinations containing Ezetimibe

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.