Regulatory PathRegulatory requirements compared

Active substance

Albendazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALBENDA 100MG\5ML SUSP20 mg/mlSuspension · Oral use1 BottleSAR 12.20NCE · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ALBENDA 200 MG TAB200 mgFilm-coated tablet · Oral use2 BlisterSAR 6.15NCE · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ASCARIASIS; GIARDIA LAMBLIA INFECTION; HOOKWORM; HOOKWORM-CUTANEOUS LARVA MIGRANS; PINWORM (ENTEROBIASIS, OXYURIASIS, THREADWORM); STRONGYLOIDIASIS; TAENIASIS; TRAVEL RELATED INFECTIONS-TREATMENT; TRICHINELLOSIS (ALSO KNOWN AS TRICHINOSIS); TRICHURIASIS (ALSO KNOWN AS WHIPWORM INFECTION)

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

ProductStrengthForm · routeApplicantStatusFirst approved
ALBENDAZOLE200MGtablet · oralZYDUS PHARMSPrescription14 Dec 2018
ALBENDAZOLE200MGtablet · oralEDENBRIDGE PHARMSPrescription14 May 2019
ALBENDAZOLE200MGtablet · oralACTAVIS ELIZABETHPrescription20 May 2019
ALBENDAZOLE200MGtablet · oralMSNPrescription22 Jan 2021
ALBENDAZOLE200MGtablet · oralDR REDDYSPrescription26 Jan 2021
ALBENDAZOLE200MGtablet · oralALEMBICPrescription4 Sep 2024
ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralIMPAX LABS INCDiscontinued11 Jun 1996
ALBENDAZOLE200MGtablet · oralCIPLA LTDDiscontinued21 Sep 2018
ALBENDAZOLE200MGtablet · oralSTRIDES PHARMADiscontinued7 Dec 2018
ALBENDAZOLE200MGtablet · oralCHARTWELL RXDiscontinued10 Jun 2020

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACALBENDAZOLE 200 MG TABLET$4.14581per EA23 Sep 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)

  • 6.1.1. Intestinal anthelminthics · core
    Echinococcosis; Cysticercosis; Hookworm diseases; Trichuriasis; Ascariasis; Enterobiasis
    Oral > Solid > tablet: 400 mg (chewable, scored)
  • 6.1.4. Cysticidal medicines · complementary
    Other specified echinococcosis; Cysticercosis of central nervous system
    Oral > Solid > tablet: 400 mg (chewable, scored); 200 mg (chewable) (EMLc)
  • 6.1.2. Antifilarials · core
    Lymphatic filariasis
    Oral > Solid > tablet: 400 mg (chewable, scored)

Safety signals and safety-related labeling changes

  • US FDA 11 Jul 2019 ALBENZA — 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 albendazole →

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.