Regulatory PathRegulatory requirements compared

Active substance

Lansoprazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LANFAST 30MG CAPSULE30 mgCapsule · Oral use15 BlisterSAR 58.10Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
LANSOMID 30 MG CAPSULE30 mgCapsule · Oral use14 BlisterSAR 35.15Generic · PrescriptionMiddle East Pharmaceutical and Chemical Industries and Medical Appliances Co.Valid
LONZET 15MG CAPSULES15 mgCapsule, hard · Oral use14 BottleSAR 13.25Generic · OTCTabuk Pharmaceutical Manufacturing CompanyValid
LONZET 30MG CAPSULES30 mgCapsule, hard · Oral use14 BottleSAR 26.50Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
PEPTAZOLE 15MG CAPSULE15 mgCapsule · Oral use14 BlisterSAR 22.95Generic · OTCSPIMACO ADDWAEIHValid
PEPTAZOLE 15MG CAPSULE15 mgCapsule · Oral use28 BlisterSAR 45.90Generic · PrescriptionSPIMACO ADDWAEIHValid
PEPTAZOLE 30MG CAPSULE30 mgCapsule · Oral use14 BlisterSAR 45.95Generic · PrescriptionSPIMACO ADDWAEIHValid
PEPTAZOLE 30MG CAPSULE30 mgCapsule · Oral use28 BlisterSAR 91.90Generic · PrescriptionSPIMACO ADDWAEIHValid
TAKEPRON 15MG CAP.15 mgCapsule, hard · Oral use14 BlisterSAR 22.95Generic · OTCAPMValid
TAKEPRON 30MG CAPS30 mgCapsule, hard · Oral use14 BlisterSAR 45.95Generic · PrescriptionAPMValid
LANZOR 15MG CAPSULE15 mgCapsule · Oral use30 BottleSAR 49.25Generic · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
LANZOR 15MG CAPSULE15 mgCapsule · Oral use30 BottleSAR 93.00Generic · PrescriptionSANOFI WINTHROP INDUSTRIEWithdrawn by MAH · Not Marketed
LANZOR 30 MG CAPSUL30 mgCapsule · Oral use15 BottleSAR 49.25Generic · PrescriptionSANOFI WINTHROP INDUSTRIEWithdrawn by MAH · Not Marketed
ULTRAZOLE15 mgCapsule · Oral use14 BlisterSAR 29.50Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
ULTRAZOLE30 mgCapsule · Oral use28 BlisterSAR 50.70Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; CORONARY ARTERY DISEASE; DENTAL ABSCESS-DENTAL PAIN; DYSPEPSIA; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GASTROESOPHAGEAL REFLUX DISEASE (GERD); HIP AND KNEE REPLACEMENT SURGERY; LOW BACK PAIN; MIGRAINE/ HEADACHE; MYASTHENIA GRAVIS; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); PAIN MANAGEMENT IN CANCER PATIENTS; PEPTIC ULCER; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS-SUPPORTIVE CARE AND ADRS MANAGEMENT; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); THROMBOTIC THROMBOCYTOPENIC PURPURA; TUBERCULOSIS-SUPPORTIVE CARE

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

ProductStrengthForm · routeApplicantStatusFirst approved
PREVACID30MGcapsule, delayed rel pellets · oralTAKEDA PHARMS USAPrescription10 May 1995
PREVACID15MG; 30MGtablet, orally disintegrating, delayed release · oralTAKEDA PHARMS USAPrescription30 Aug 2002
PREVACID 24 HR15MGcapsule, delayed rel pellets · oralPERRIGO PHARMA INTLOver-the-counter18 May 2009
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralTEVA PHARMSPrescription10 Nov 2009
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralMYLAN PHARMS INCPrescription10 Nov 2009
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralDR REDDYS LABS LTDPrescription15 Oct 2010
LANSOPRAZOLE15MGcapsule, delayed rel pellets · oralDR REDDYS LABS LTDOver-the-counter18 May 2012
LANSOPRAZOLE15MGcapsule, delayed rel pellets · oralPERRIGO R AND DOver-the-counter18 May 2012
LANSOPRAZOLE15MGcapsule, delayed rel pellets · oralGLENMARK PHARMSOver-the-counter18 May 2012
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralAPOTEXPrescription14 Sep 2012
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralNATCO PHARMA LTDPrescription18 Dec 2012
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralZYDUS HLTHCAREPrescription19 Aug 2013
LANSOPRAZOLE15MGcapsule, delayed rel pellets · oralNATCOOver-the-counter13 Jan 2016
LANSOPRAZOLE15MGtablet, orally disintegrating, delayed release · oralDEXCELOver-the-counter7 Jun 2016
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralXIROMEDPrescription25 Jul 2016
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralADAPTISPrescription30 Aug 2017
LANSOPRAZOLE15MG; 30MGtablet, orally disintegrating, delayed release · oralTEVA PHARMS USAPrescription21 Sep 2017
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralCHARTWELL MOLECULARPrescription28 Sep 2017
LANSOPRAZOLE15MG; 30MGtablet, orally disintegrating, delayed release · oralZYDUS PHARMSPrescription27 Nov 2018
LANSOPRAZOLE15MG; 30MGtablet, orally disintegrating, delayed release · oralMYLANPrescription28 Nov 2018
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralALKEM LABS LTDPrescription18 Jan 2019
LANSOPRAZOLE15MG; 30MGcapsule, delayed rel pellets · oralHETERO LABS LTD IIIPrescription18 May 2020
LANSOPRAZOLE15MG; 30MGtablet, orally disintegrating, delayed release · oralDR REDDYSPrescription1 Feb 2021
LANSOPRAZOLE15MG; 30MGtablet, orally disintegrating, delayed release · oralAUROBINDO PHARMA LTDPrescription28 Mar 2023
PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule, delayed rel pellets · oralTAKEDA PHARMS USADiscontinued10 May 1995

12 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-LANSOPRAZOLE0229381115 MGCAPSULE (DELAYED-RELEASE) · ORALAPOTEX INC
APO-LANSOPRAZOLE0229383830 MGCAPSULE (DELAYED-RELEASE) · ORALAPOTEX INC
LANSOPRAZOLE0235768215 MGCAPSULE (DELAYED-RELEASE) · ORALSANIS HEALTH INC
LANSOPRAZOLE0235769030 MGCAPSULE (DELAYED-RELEASE) · ORALSANIS HEALTH INC
LANSOPRAZOLE0238576715 MGCAPSULE (DELAYED-RELEASE) · ORALSIVEM PHARMACEUTICALS ULC
LANSOPRAZOLE0241038930 MGCAPSULE (DELAYED-RELEASE) · ORALSIVEM PHARMACEUTICALS ULC
MYLAN-LANSOPRAZOLE0235383015 MGCAPSULE (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-LANSOPRAZOLE0235384930 MGCAPSULE (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
NB-LANSOPRAZOLE0256123915 MGCAPSULE (DELAYED-RELEASE) · ORALNB PHARMA INC.
NB-LANSOPRAZOLE0256124730 MGCAPSULE (DELAYED-RELEASE) · ORALNB PHARMA INC.
PREVACID0216550315 MGCAPSULE (DELAYED-RELEASE) · ORALTAKEDA PHARMACEUTICALS AMERICA INC
PREVACID0216551130 MGCAPSULE (DELAYED-RELEASE) · ORALTAKEDA PHARMACEUTICALS AMERICA INC
PREVACID FASTAB0224946415 MGTABLET (DELAYED-RELEASE) · ORALTAKEDA PHARMACEUTICALS AMERICA INC
PREVACID FASTAB0224947230 MGTABLET (DELAYED-RELEASE) · ORALTAKEDA PHARMACEUTICALS AMERICA INC
PRO-LANSOPRAZOLE0236628230 MGCAPSULE (DELAYED-RELEASE) · ORALPRO DOC LIMITEE
SANDOZ LANSOPRAZOLE0238564315 MGCAPSULE (DELAYED-RELEASE) · ORALSANDOZ CANADA INCORPORATED
SANDOZ LANSOPRAZOLE0238565130 MGCAPSULE (DELAYED-RELEASE) · ORALSANDOZ CANADA INCORPORATED
TARO-LANSOPRAZOLE0240261015 MGCAPSULE (DELAYED-RELEASE) · ORALSUN PHARMA CANADA INC
TARO-LANSOPRAZOLE0240262930 MGCAPSULE (DELAYED-RELEASE) · ORALSUN PHARMA CANADA INC
TEVA-LANSOPRAZOLE0228051515 MGCAPSULE (DELAYED-RELEASE) · ORALTEVA CANADA LIMITED
TEVA-LANSOPRAZOLE0228052330 MGCAPSULE (DELAYED-RELEASE) · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACGNP LANSOPRAZOLE DR 15 MG CAP$0.40674per EA23 Sep 2026
US NADACGS LANSOPRAZOLE DR 15 MG CAP$0.40674per EA23 Sep 2026
US NADACLANSOPRAZOLE DR 15 MG CAPSULE$0.14737per EA23 Sep 2026
US NADACLANSOPRAZOLE DR 15 MG CAPSULE$0.40674per EA23 Sep 2026
US NADACLANSOPRAZOLE DR 15 MG ODT$1.92192per EA23 Sep 2026
US NADACLANSOPRAZOLE DR 30 MG CAPSULE$0.1061per EA23 Sep 2026
US NADACLANSOPRAZOLE DR 30 MG ODT$2.25583per EA23 Sep 2026
US NADACPREVACID DR 15 MG SOLUTAB$13.24954per EA23 Sep 2026
US NADACPREVACID DR 30 MG CAPSULE$13.2194per EA23 Sep 2026
US NADACPREVACID DR 30 MG SOLUTAB$13.21469per EA23 Sep 2026
US NADACQC LANSOPRAZOLE DR 15 MG CAP$0.40674per EA23 Sep 2026
NHS Drug TariffLansoprazole 15mg gastro-resistant capsules£0.8628 capsule1 Oct 2026
NHS Drug TariffLansoprazole 15mg orodispersible tablets£2.6628 tablet1 Oct 2026
NHS Drug TariffLansoprazole 30mg gastro-resistant capsules£1.1528 capsule1 Oct 2026
NHS Drug TariffLansoprazole 30mg orodispersible tablets£5.1028 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

All safety entries for lansoprazole →

Combinations containing Lansoprazole

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.