FDA — authorised 21 December 2004
- Application: NDA021706
- Marketing authorisation holder: SANTARUS
- Local brand name: ZEGERID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 omeprazole/sodium bicarbonate in United States
FDA authorised omeprazole/sodium bicarbonate on 21 December 2004 · 232 US adverse-event reports
Marketing authorisations
FDA — authorised 27 February 2006
- Application: NDA021849
- Marketing authorisation holder: SALIX
- Local brand name: ZEGERID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 March 2006
- Application: NDA021850
- Marketing authorisation holder: SANTARUS
- Local brand name: ZEGERID
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 19 April 2013
- Application: ANDA079182
- Marketing authorisation holder: STRIDES PHARMA INTL
- Status: supplemented
FDA — authorised 6 December 2016
- Application: ANDA207476
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: supplemented
FDA — authorised 30 April 2020
- Application: ANDA212587
- Marketing authorisation holder: ANDA REPOSITORY
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 232
Most-reported reactions
- Chronic Kidney Disease — 40 reports (17.24%)
- Fatigue — 29 reports (12.5%)
- Nausea — 25 reports (10.78%)
- Drug Ineffective — 24 reports (10.34%)
- Renal Failure — 24 reports (10.34%)
- Diarrhoea — 21 reports (9.05%)
- Headache — 18 reports (7.76%)
- Acute Kidney Injury — 17 reports (7.33%)
- Death — 17 reports (7.33%)
- Pain — 17 reports (7.33%)
Other Gastroenterology approved in United States
Frequently asked questions
Is omeprazole/sodium bicarbonate approved in United States?
Yes. FDA authorised it on 21 December 2004; FDA authorised it on 27 February 2006; FDA authorised it on 24 March 2006.
Who is the marketing authorisation holder for omeprazole/sodium bicarbonate in United States?
SANTARUS holds the US marketing authorisation.