Overview

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Indication

Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults

Associated Conditions

Ankylosing Spondylitis (AS)
Duodenal Ulcer
Erosive Esophagitis
Gastric Ulcer
Gastro-esophageal Reflux Disease (GERD)
Healing
Heartburn
Helicobacter Pylori Infection
Osteoarthritis (OA)
Rheumatoid Arthritis
Upper GI Bleeding
Zollinger-Ellison Syndrome
Benign, active Gastric Ulcer
Develop NSAID-induced gastric ulcers
Hypersecretory conditions
Multiple endocrine adenomas

Research Report

Published: Jul 18, 2025

A Comprehensive Monograph on Omeprazole (DB00338): From Molecular Mechanism to Clinical Practice

Introduction and Drug Identification

Overview and Significance

Omeprazole is a seminal small molecule drug that represents a cornerstone in the management of acid-related gastrointestinal disorders.[1] As the first clinically successful proton pump inhibitor (PPI), its introduction marked a paradigm shift in gastroenterology, offering a level of gastric acid suppression that was significantly more potent and sustained than previously available agents like histamine-2 receptor antagonists (

H2RAs).[2] Classified chemically as a substituted benzimidazole, omeprazole has demonstrated profound efficacy in treating conditions ranging from gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD) to rare hypersecretory states.[1] Its global importance is underscored by its inclusion on the World Health Organization's List of Essential Medicines and its immense prescription volume; in 2022, it was the ninth most commonly prescribed medication in the United States, accounting for over 52 million prescriptions.[6]

Historical Context and Regulatory Milestones

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection	2025/06/27	NCT07040839	Not Applicable	Not yet recruiting	Rehman Medical Institute - RMI
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial	2025/06/26	NCT07037888	Phase 4	Recruiting	Henry Ford Health System
The Mechanism Versus PPI Trial	2025/05/31	NCT06999577	Phase 4	Recruiting	University of California, San Diego
A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants	2025/04/28	NCT06948006	Phase 1	Completed	AstraZeneca
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease	2025/04/24	NCT06943482	Phase 4	Not yet recruiting	National University Hospital, Singapore
Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride	2025/02/12	NCT06822166	Phase 1	Completed	Ahon Pharmaceutical Co., Ltd.
Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum	2024/12/06	NCT06719622	Phase 2	ENROLLING_BY_INVITATION	Medical University of Warsaw
Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone	2024/11/15	NCT06690164	Phase 4	Recruiting	National University Hospital, Singapore
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates	2024/11/13	NCT06686628	Phase 1	Active, not recruiting	Sanofi
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants	2024/09/20	NCT06605950	Phase 1	Completed	Karuna Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Omeprazole	A-S Medication Solutions	50090-7018	ORAL	20 mg in 1 1	5/11/2023
Omeprazole	NorthStar Rx LLC	16714-123	ORAL	40 mg in 1 1	6/15/2023
Omeprazole	Unit Dose Services	50436-8158	ORAL	20 mg in 1 1	11/12/2020
Omeprazole	Bryant Ranch Prepack	71335-0559	ORAL	10 mg in 1 1	2/18/2022
Omeprazole	Quallent Pharmaceuticals Health LLC	82009-023	ORAL	40 mg in 1 1	4/20/2023
OMEPRAZOLE DR	Direct Rx	61919-176	ORAL	20 mg in 1 1	5/31/2023
Omeprazole	RedPharm Drug, Inc.	67296-0706	ORAL	20 mg in 1 1	1/19/2022
Omeprazole and Sodium Bicarbonate	ScieGen Pharmaceuticals, Inc.	50228-363	ORAL	20 mg in 1 1	11/6/2023
Omeprazole	Aurobindo Pharma Limited	59651-001	ORAL	10 mg in 1 1	4/17/2023
Omeprazole Delayed-Release	Ranbaxy Laboratories Inc.	63304-445	ORAL	40 mg in 1 1	8/25/2009

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
OMICAP CAPSULE 20 mg	MICRO LABS LTD	SIN09987P	CAPSULE	20 mg	9/11/1998
OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL	Aspiro Pharma Limited	SIN16330P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 mg/ vial	9/22/2021
OMESEC CAPSULE 20 mg	DUOPHARMA MANUFACTURING (BANGI) SDN BHD	SIN11519P	CAPSULE	20 mg	5/16/2001
PROCEPTIN 20 CAPSULE 20 mg	BEXIMCO PHARMACEUTICALS LTD	SIN10186P	CAPSULE	20 mg	10/6/1998
ZENPRO CAPSULE 20MG (PHARMACY ONLY)	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD, HETERO DRUGS LIMITED	SIN15725P	CAPSULE	20.00 mg	6/25/2019
PENRAZOL ENTERIC COATED CAPSULE 20 mg	ELPEN PHARMACEUTICAL CO INC	SIN11747P	CAPSULE	20 mg	12/26/2001
PROMESEC GASTRO-RESISTANT CAPSULES 20 MG (PHARMACY ONLY)	Hetero Labs Limited (Unit-III)	SIN16251P	CAPSULE, ENTERIC COATED	20.000 mg	6/28/2021
OMEZOLE 20 CAPSULE 20 mg	HOVID BHD, HOVID Bhd.	SIN11981P	CAPSULE	20.00 mg	6/5/2002
OMEPRADEX EC TABLET 20mg	DEXCEL LIMITED, DEXCEL PHARMA TECHNOLOGIES LTD	SIN14019P	TABLET, ENTERIC COATED	20 mg	9/22/2011
OCID CAPSULE 20 mg	CADILA HEALTHCARE LTD	SIN11893P	CAPSULE	20 mg	4/24/2002

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
GASEC-20 CAP 20MG (E.C. PELLETS)	N/A	CEUTICAL TRADING COMPANY LIMITED	N/A	N/A	7/30/2002
GOMEC CAP 20MG (E.C. GRANULES)	N/A	TRENTON-BOMA LIMITED	N/A	N/A	7/9/2002
EPRAZOLE CAP 20MG	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	2/14/2003
OMIZEC CAP 20MG (ENTERIC COATED PELLETS)	N/A	MEDREICH FAR EAST LIMITED	N/A	N/A	11/16/2009
OMEPRAZOLE CAP 20MG (ENTERIC COATED PELLETS)	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	8/11/2006
LOMAC-20 CAP 20MG (E.C. GRANULES)	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/19/2002
LOSCID GASTRO RESISTANT CAPSULES 20MG	N/A	R. MANSTIEN (AUSTRALIA) LIMITED	N/A	N/A	9/4/2017
OMEPRAZOLE JEAN-MARIE GASTRO-RESISTANT CAPSULES 20MG	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	12/22/2022

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MAXOR HEARTBURN RELIEF omeprazole 20 mg enteric capsule blister pack (new formulation)	180913	Alphapharm Pty Ltd	Medicine	A	3/7/2011
OMEPRAZOLE SANDOZ omeprazole (as magnesium) 10 mg enteric-coated tablet blister pack	176178	Sandoz Pty Ltd	Medicine	A	3/8/2012
OMEPRAZOLE MUPS AZN omeprazole 20 mg (as magnesium) tablet blister pack	351171	AstraZeneca Pty Ltd	Medicine	A	1/27/2021
OMEPRAZOLE SANDOZ omeprazole 20 mg enteric capsule bottle	82474	Sandoz Pty Ltd	Medicine	A	5/27/2002
OMEPRAZOLE-WGR omeprazole 20 mg enteric-coated tablet blister	444390	Medis Pharma Pty Ltd	Medicine	A	1/2/2025
OMEPRAZOLE KMS omeprazole 20 mg enteric-coated tablet blister pack	190417	Medis Pharma Pty Ltd	Medicine	A	9/10/2012
OMEPRAZOLE ADVZ omeprazole 2 mg/mL powder for suspension bottle	391771	Boucher & Muir Pty Ltd	Medicine	A	4/28/2023
OMEPRAL omeprazole (as magnesium) 20mg tablet blister pack	120594	Pharmaco Australia Ltd	Medicine	A	11/1/2005
PROBITOR omeprazole 20 mg enteric capsule blister pack	82757	Sandoz Pty Ltd	Medicine	A	6/25/2002
LOSEC omeprazole 10mg (as magnesium) tablet blister pack	63414	Pharmaco Australia Ltd	Medicine	A	12/14/1998

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OMEPRAZOLE-20	sivem pharmaceuticals ulc	02411857	Capsule (Delayed Release) - Oral	20 MG	10/23/2013
MYLAN-OMEPRAZOLE	Mylan Pharmaceuticals ULC	02329433	Capsule (Delayed Release) - Oral	20 MG	8/4/2009
HEARTBURN CONTROL	Apotex Inc	02435683	Capsule (Delayed Release) - Oral	20 MG	3/12/2015
SANDOZ OMEPRAZOLE	Sandoz Canada, Inc.	02296438	Capsule (Delayed Release) - Oral	10 MG	9/14/2007
LOSEC CAPSULES 10MG	astrazeneca canada inc	02119579	Capsule (Delayed Release) - Oral	10 MG	10/3/2000
Q-OMEPRAZOLE	qd pharmaceuticals ulc	02372274	Capsule (Delayed Release) - Oral	20 MG	2/3/2012
PMS-OMEPRAZOLE	Pharmascience Inc	02320843	Capsule (Delayed Release) - Oral	10 MG	N/A
AVA-OMEPRAZOLE	avanstra inc	02364352	Capsule (Delayed Release) - Oral	20 MG	11/28/2011
MYLAN-OMEPRAZOLE	Mylan Pharmaceuticals ULC	02329425	Capsule (Delayed Release) - Oral	10 MG	8/4/2009
Q-OMEPRAZOLE	qd pharmaceuticals ulc	02372258	Capsule (Delayed Release) - Oral	10 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OMEPRAZOL COMBIX 20 mg CAPSULAS DURAS GASTRORRESISTENTES EFG	Laboratorios Combix S.L.U.	69139	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Commercialized
ARAPRIDE 40 mg CAPSULAS DURAS GASTRORRESISTENTES	Arafarma Group S.A.	65688	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Commercialized
OMECOD 20 MG CAPSULAS DURAS GASTRORRESISTENTES EFG	Towa Pharmaceutical Europe S.L.	83838	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OMEPRAZOL VIATRIS PHARMACEUTICALS 20 MG CAPSULAS DURAS GASTRORRESISTENTES	Viatris Pharmaceuticals S.L.U.	86474	CÁPSULA DURA GASTRORRESISTENTE	Sin Receta	Commercialized
OMEPRAZOL ARISTO 40 mg CAPSULAS DURAS GASTRORRESISTENTES	Aristo Pharma Iberia S.L.	67273	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Commercialized
OMPRANYT 20 mg CAPSULAS DURAS GASTRORRESISTENTES	Laboratorios Bial S.A.	59807	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OMEPRAZOL HIKMA 40 MG POLVO PARA SOLUCION PARA PERFUSION EFG	Hikma Farmaceutica (Portugal) S.A.	88970	POLVO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
OMEPRAZOL TEVA GROUP 40 mg CAPSULAS DURAS GASTRORRESISTENTES	Teva Pharma S.L.U.	68794	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BELMAZOL 10 mg CAPSULAS DURAS GASTRORRESISTENTES	Teva Pharma S.L.U.	65515	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OMEPRAZOL CINFA 20 mg CAPSULAS DURAS GASTRORRESISTENTES EFG	Laboratorios Cinfa S.A.	63983	CÁPSULA DURA GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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