Regulatory PathRegulatory requirements compared

Active substance

Omeprazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ACILOC40 mgGastro-resistant capsule, hard · Oral use28 BlisterSAR 120.30Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACILOC40 mgGastro-resistant capsule, hard · Oral use7 BlisterSAR 30.50Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACILOC40 mgGastro-resistant capsule, hard · Oral use14 BlisterSAR 61.00Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACILOC20 mgGastro-resistant capsule, hard · Oral use28 BlisterSAR 88.90Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACILOC20 mgGastro-resistant capsule, hard · Oral use14 BlisterSAR 45.95Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACILOC20 mgGastro-resistant capsule, hard · Oral use7 BlisterSAR 22.95Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
Bloka40Powder and solvent for solution for infusion · Intravenous use1 VialSAR 22.40Generic · PrescriptionAdvanced Pharmaceutical IndustriesValid
EMILOK 20MG CAPSULES20 mgCapsule · Oral use14 BottleSAR 37.20Generic · PrescriptionGLOBAL PHARMAValid
EPIRAZOLE 20MG CAPS(E.C.PELLETS)20 mgCapsule · Oral use14 BlisterSAR 23.35Generic · PrescriptionEIPICOValid
Emilok40 mgGastro-resistant capsule, hard · Oral use14 BottleSAR 45.10Generic · PrescriptionGLOBAL PHARMA CO LLCValid
Emopack40 mgPowder for solution for injection/infusion · Intravenous use1 VialSAR 22.50Generic · PrescriptionSPIMACO ADDWAEIHValid
Emopack40 mgPowder for solution for injection/infusion · Intravenous use10 VialSAR 225.00Generic · PrescriptionSPIMACOValid
GASEC 20MG GASTRO CAPS20 mgGastro-resistant capsule, hard · Oral use28 BlisterSAR 48.40Generic · PrescriptionALPHA PHARMA INDUSTRYValid
GASEC 20MG GASTRO CAPS20 mgGastro-resistant capsule, hard · Oral use14 BlisterSAR 27.50Generic · PrescriptionALPHA PHARMA INDUSTRYValid
GASEC 40MG GASTRO CAPSULES40 mgGastro-resistant capsule, hard · Oral use28 BlisterSAR 79.35Generic · PrescriptionALPHA PHARMA INDUSTRYValid
GASEC 40MG GASTRO CAPSULES40 mgGastro-resistant capsule, hard · Oral use14 BlisterSAR 45.10Generic · PrescriptionALPHA PHARMA INDUSTRYValid
HYPOSEC 20 MG CAPSULE20 mgCapsule · Oral use14 BlisterSAR 31.60Generic · PrescriptionRam Pharmaceutical IndustriesValid
LOSEC MUPS 10 MG TAB10 mgGastro-resistant tablet · Oral use14 BlisterSAR 23.00NCE · PrescriptionCHEPLAPHARM Arzneimittel GmbHValid
LOSEC MUPS 20MG TAB20 mgGastro-resistant tablet · Oral use14 BlisterSAR 45.95NCE · PrescriptionCHEPLAPHARM Arzneimittel GmbHValid
OMECURE 40 MG POWDER FOR I.V. INJECTION40 mgpowder for solution for injection · Intravenous use10 VialSAR 270.90Generic · PrescriptionLES LABORATOIRES MEDISValid
OMEPREX 20 mg capsule20 mgCapsule · Oral use14 BlisterSAR 45.95Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
OMEPREX 20 mg capsule20 mgCapsule · Oral use28 BlisterSAR 91.90Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
OMERAL 10 mg capsule10 mgCapsule · Oral use14 BlisterSAR 22.95Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
OMERAL 20 mg capsule20 mgCapsule · Oral use14 BlisterSAR 45.95Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
OMISEC40 mgPowder for solution for infusion · Intravenous use1 VialSAR 22.50Generic · PrescriptionMS Pharma Saudi (MSPS)Valid

16 more — full table

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; BARIATRIC SURGERY; CORONARY ARTERY DISEASE; DENTAL ABSCESS-DENTAL PAIN; DYSPEPSIA; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GASTROESOPHAGEAL REFLUX DISEASE (GERD); LOW BACK PAIN; MARGINAL ZONE LYMPHOMA; 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
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralLANNETT CO INCPrescription1 Nov 2002
OMEPRAZOLE10MG; 20MGcapsule, delayed rel pellets · oralSANDOZPrescription28 Jan 2003
PRILOSEC OTCEQ 20MG BASEtablet, delayed release · oralASTRAZENECAOver-the-counter20 Jun 2003
OMEPRAZOLE40MG; 20MG; 10MGcapsule, delayed rel pellets · oralDR REDDYS LABS LTDPrescription22 Oct 2007
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralIMPAX LABSPrescription22 Oct 2007
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralAPOTEXPrescription22 Oct 2007
OMEPRAZOLE20MGtablet, delayed release · oralDEXCEL PHARMAOver-the-counter4 Dec 2007
PRILOSECEQ 2.5MG BASE/PACKET; EQ 10MG BASE/PACKETfor suspension, delayed release · oralAZURITYPrescription20 Mar 2008
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralACTAVIS LABS FL INCPrescription30 May 2008
OMEPRAZOLE40MGcapsule, delayed rel pellets · oralSANDOZPrescription21 Jan 2009
OMEPRAZOLE40MG; 10MG; 20MGcapsule, delayed rel pellets · oralDR REDDYS LABS LTDPrescription17 Apr 2009
OMEPRAZOLE MAGNESIUMEQ 20MG BASEcapsule, delayed release · oralDR REDDYS LABS LTDOver-the-counter5 Jun 2009
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralZYDUS PHARMS USA INCPrescription19 Nov 2012
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralGLENMARK PHARMS LTDPrescription31 Oct 2014
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralAUROBINDO PHARMAPrescription19 Aug 2015
OMEPRAZOLE20MGcapsule, delayed rel pellets · oralTEVA PHARMS USAPrescription13 Jun 2017
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralBRECKENRIDGEPrescription3 Jul 2017
OMEPRAZOLE20MGtablet, orally disintegrating, delayed release · oralDEXCELOver-the-counter5 Jul 2017
OMEPRAZOLE MAGNESIUMEQ 20MG BASEtablet, delayed release · oralAUROBINDO PHARMAOver-the-counter6 Jun 2018
OMEPRAZOLE20MGtablet, delayed release · oralSUN PHARMOver-the-counter12 Oct 2018
OMEPRAZOLE20MGtablet, delayed release · oralDR REDDYSOver-the-counter5 Nov 2018
OMEPRAZOLE10MG; 20MGcapsule, delayed rel pellets · oralHETERO LABS LTD IIIPrescription26 Sep 2019
OMEPRAZOLE MAGNESIUMEQ 20MG BASEtablet, delayed release · oralHETERO LABS LTD IIIOver-the-counter25 Mar 2020
OMEPRAZOLE MAGNESIUMEQ 20MG BASEtablet, delayed release · oralP AND LOver-the-counter1 Jun 2020
OMEPRAZOLE10MG; 20MG; 40MGcapsule, delayed rel pellets · oralXIROMEDPrescription10 Dec 2020

11 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-OMEPRAZOLE0224505820 MGCAPSULE (DELAYED-RELEASE) · ORALAPOTEX INC
BIO-OMEPRAZOLE0244992720 MGTABLET (DELAYED-RELEASE) · ORALBIOMED PHARMA
HEARTBURN CONTROL0243568320 MGCAPSULE (DELAYED-RELEASE) · ORALAPOTEX INC
JAMP-OMEPRAZOLE DR0242019820 MGTABLET (DELAYED-RELEASE) · ORALJAMP PHARMA CORPORATION
LOSEC0084650320 MGCAPSULE (DELAYED-RELEASE) · ORALCHEPLAPHARM ARZNEIMITTEL GMBH
LOSEC MUPS0224246220 MGTABLET (DELAYED-RELEASE) · ORALCHEPLAPHARM ARZNEIMITTEL GMBH
OMEPRAZOLE0233992720 MGCAPSULE (DELAYED-RELEASE) · ORALPRO DOC LIMITEE
OMEPRAZOLE0234869120 MGCAPSULE (DELAYED-RELEASE) · ORALSANIS HEALTH INC
OMEPRAZOLE-200241185720 MGCAPSULE (DELAYED-RELEASE) · ORALSIVEM PHARMACEUTICALS ULC
TEVA-OMEPRAZOLE0229540710 MGTABLET (DELAYED-RELEASE) · ORALTEVA CANADA LIMITED
TEVA-OMEPRAZOLE0229541520 MGTABLET (DELAYED-RELEASE) · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFT OMEPRAZOLE DR 20 MG TABLET$0.3832per EA23 Sep 2026
US NADACGNP OMEPRAZOLE DR 20 MG TABLET$0.3832per EA23 Sep 2026
US NADACGS OMEPRAZOLE DR 20 MG ODT$0.4682per EA23 Sep 2026
US NADACGS OMEPRAZOLE DR 20 MG TABLET$0.3832per EA23 Sep 2026
US NADACOMEPRAZOLE DR 10 MG CAPSULE$0.07662per EA23 Sep 2026
US NADACOMEPRAZOLE DR 20 MG CAPSULE$0.02945per EA23 Sep 2026
US NADACOMEPRAZOLE DR 20 MG ODT$0.4682per EA23 Sep 2026
US NADACOMEPRAZOLE DR 20 MG TABLET$0.3832per EA23 Sep 2026
US NADACOMEPRAZOLE DR 40 MG CAPSULE$0.04982per EA23 Sep 2026
US NADACOMEPRAZOLE MAG DR 20 MG CAP$0.39509per EA23 Sep 2026
US NADACOMEPRAZOLE MAG DR 20 MG TABLET$0.47306per EA23 Sep 2026
US NADACOMEPRAZOLE MAG DR 20.6 MG CAP$0.39509per EA23 Sep 2026
NHS Drug TariffOmeprazole 10mg dispersible gastro-resistant tablets£11.4128 tablet1 Oct 2026
NHS Drug TariffOmeprazole 10mg gastro-resistant capsules£0.8628 capsule1 Oct 2026
NHS Drug TariffOmeprazole 10mg gastro-resistant tablets£10.0228 tablet1 Oct 2026
NHS Drug TariffOmeprazole 10mg/5ml oral suspension sugar free£136.7975 ml1 Oct 2026
NHS Drug TariffOmeprazole 1mg/ml oral suspension sugar free£122.4575 ml1 Oct 2026
NHS Drug TariffOmeprazole 20mg dispersible gastro-resistant tablets£16.7628 tablet1 Oct 2026
NHS Drug TariffOmeprazole 20mg gastro-resistant capsules£0.8328 capsule1 Oct 2026
NHS Drug TariffOmeprazole 20mg gastro-resistant tablets£6.6228 tablet1 Oct 2026
NHS Drug TariffOmeprazole 20mg/5ml oral suspension sugar free£258.1375 ml1 Oct 2026
NHS Drug TariffOmeprazole 40mg dispersible gastro-resistant tablets£8.607 tablet1 Oct 2026
NHS Drug TariffOmeprazole 40mg gastro-resistant capsules£0.677 capsule1 Oct 2026
NHS Drug TariffOmeprazole 40mg gastro-resistant tablets£10.397 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.

WHO WHO Model List of Essential Medicines (2025)

  • 17.1. Antiulcer medicines · core
    Gastrointestinal bleeding; Peptic ulcer, site unspecified; Gastro-oesophageal reflux disease
    Parenteral > General injections > IV: 40 mg in vial (EML) | Oral > Liquid: 1 mg per mL powder for oral liquid; 4 mg per mL powder for oral liquid | Oral > Solid > dosage form: 10 mg; 20 mg; 40 mg

Safety signals and safety-related labeling changes

All safety entries for omeprazole →

Combinations containing Omeprazole

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.