Is Omeprazole + Sodium bicarbonate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Omeprazole + Sodium bicarbonate, including Byraza Plus (40,1100 mg,mg, Capsule, SAR 87.50); Byraza Plus (20,1100 mg,mg, Capsule, hard, SAR 43.75); GASTROZOLE PLUS 20 MG/1100 MG CAPSULE (20,1100 mg,mg, Capsule, SAR 50.15); GASTROZOLE PLUS 40/1100 MG CAPSULES (40,1100 mg,mg, Capsule, SAR 114.00); OMIZ PLUS 20MG CAPSULE (20,1100 mg,mg, Capsule, SAR 52.80).

Is Omeprazole + Sodium bicarbonate approved by the US FDA?

Drugs@FDA lists 22 application product lines for Omeprazole + Sodium bicarbonate, including ZEGERID OTC (Over-the-counter); OMEPRAZOLE AND SODIUM BICARBONATE (Prescription); ZEGERID OTC (Over-the-counter); OMEPRAZOLE AND SODIUM BICARBONATE (Over-the-counter); OMEPRAZOLE AND SODIUM BICARBONATE (Prescription).

Active substances

Omeprazole + Sodium bicarbonate

SFDA 10
US FDA 22
US price lines 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Byraza Plus	40,1100 mg,mg	Capsule · Oral use	28 Blister	SAR 87.50	Generic · Prescription	Alrazi Pharmaceutical Industries Factory Co	Valid
Byraza Plus	20,1100 mg,mg	Capsule, hard · Oral use	28 Blister	SAR 43.75	Generic · Prescription	Alrazi Pharmaceutical Industries Factory Co	Valid
GASTROZOLE PLUS 20 MG/1100 MG CAPSULE	20,1100 mg,mg	Capsule · Oral use	28 Bottle	SAR 50.15	Generic · Prescription	RIYADH PHARMA	Valid
GASTROZOLE PLUS 40/1100 MG CAPSULES	40,1100 mg,mg	Capsule · Oral use	28 Bottle	SAR 114.00	Generic · Prescription	RIYADH PHARMA	Valid
OMIZ PLUS 20MG CAPSULE	20,1100 mg,mg	Capsule · Oral use	28 Blister	SAR 52.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OMIZ PLUS 40MG CAPSULE	40,1100 mg,mg	Capsule · Oral use	28 Blister	SAR 120.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Omeprex Plus	40,1100 mg,mg	Capsule · Oral use	30 Blister	SAR 93.75	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Omezyn Plus	40,1100 mg,mg	Capsule, hard · Oral use	28 Blister	SAR 92.65	Generic · Prescription	OMAN PHARMACEUTICAL PRODUCTS	Valid
Risek Plus	40,1100 mg,mg	Capsule · Oral use	30 Bottle	SAR 89.20	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
SoiCarby	40,1100 mg,mg	Capsule, hard · Oral use	28 Blister	SAR 87.50	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid

Indications — CHI Daman Drug Formulary

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; DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD); MIGRAINE/ HEADACHE; PEPTIC ULCER

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

Product	Strength	Form · route	Applicant	Status	First approved
ZEGERID OTC	20MG;1.1GM	capsule · oral	RILEY CONSUMER	Over-the-counter	1 Dec 2009
OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET; 40MG/PACKET;1.68GM/PACKET	for suspension · oral	STRIDES PHARMA INTL	Prescription	19 Apr 2013
ZEGERID OTC	20MG/PACKET;1.68GM/PACKET	for suspension · oral	RILEY CONSUMER	Over-the-counter	17 Jun 2013
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	capsule · oral	PERRIGO R AND D	Over-the-counter	15 Jul 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	DR REDDYS	Prescription	15 Jul 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	AJANTA PHARMA LTD	Prescription	15 Jul 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET; 40MG/PACKET;1.68GM/PACKET	for suspension · oral	AJANTA PHARMA LTD	Prescription	27 Jul 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	AUROLIFE PHARMA LLC	Prescription	19 Aug 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	capsule · oral	AUROBINDO PHARMA	Over-the-counter	7 Nov 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	SCIEGEN PHARMS	Prescription	6 Dec 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	capsule · oral	ZYDUS	Over-the-counter	16 Mar 2018
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	ZYDUS PHARMS	Prescription	25 May 2018
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	ADAPTIS	Prescription	30 Apr 2020
KONVOMEP	2MG/ML;84MG/ML	for suspension · oral	AZURITY	Prescription	30 Aug 2022
OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	for suspension · oral	DR REDDYS	Over-the-counter	9 May 2024
OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET; 40MG/PACKET;1.68GM/PACKET	for suspension · oral	NOVITIUM PHARMA	Prescription	10 Dec 2025
ZEGERID	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	for suspension · oral	SALIX	Discontinued	15 Jun 2004
ZEGERID	40MG/PACKET;1.68GM/PACKET	for suspension · oral	SANTARUS	Discontinued	21 Dec 2004
ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	SALIX	Discontinued	27 Feb 2006
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM; 40MG;1.1GM	capsule · oral	STRIDES PHARMA INTL	Discontinued	25 May 2010
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	capsule · oral	STRIDES PHARMA INTL	Discontinued	15 Jul 2016
OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	capsule · oral	CHARTWELL RX	Discontinued	15 Jul 2016

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KONVOMEP 2-84 MG/ML ORAL SUSP	$2.085	per ML	23 Sep 2026
US NADAC	KONVOMEP 2-84 MG/ML ORAL SUSP	$1.762	per ML	23 Sep 2026
US NADAC	KONVOMEP 2-84 MG/ML ORAL SUSP	$1.2442	per ML	23 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.

Components

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.