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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 204923


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NDA 204923 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma Intl, Zydus, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-three suppliers. Additional details are available on the OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 204923
Tradename:OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:Aurobindo Pharma
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Pharmacology for NDA: 204923
Mechanism of ActionAlkalinizing Activity
Cytochrome P450 2C19 Inhibitors
Proton Pump Inhibitors
Suppliers and Packaging for NDA: 204923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204923 ANDA Aurohealth LLC 58602-725 58602-725-05 1 BOTTLE in 1 CARTON (58602-725-05) / 14 CAPSULE in 1 BOTTLE
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204923 ANDA Aurohealth LLC 58602-725 58602-725-57 2 BOTTLE in 1 CARTON (58602-725-57) / 14 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Nov 7, 2016TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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