Medicine
Omeprazole and Sodium bicarbonate 20 mg/1100 mg capsule
Omeprazole and Sodium bicarbonate 20 mg/1100 mg capsule is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Omeprazole and Sodium bicarbonate
- Brand
- Sold under the generic name
- Strength
- 20 mg/1100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 500 capsules, 15 capsules and 6 more
- Manufacturers
- CiplaIndiaAjanta PharmaIndiaPhoenix RXScieGen PharmaceuticalsGuardian Drug
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 July 2016
- Identifiers
- RxCUI 616539, 616541DailyMed set ID 3b2bf501-fd81-6ffa-e063-6394a90afe42, a107804e-b308-4e79-9447-07d93016f70f, 9cdde58a-ae8a-451f-92cf-cab178e4ba92 +2NDC 85509-1031, 50228-363, 69097-913 +2Application ANDA204228, ANDA207476, ANDA212587
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule in 1 bottle | 27241-031-03 | Ajanta PharmaIndia | 15 July 2016 |
| 30 capsule in 1 bottle | 69097-913-02 | CiplaIndia | 30 January 2017 |
| 500 capsule in 1 bottle | 69097-913-12 | CiplaIndia | 30 January 2017 |
| 30 capsule in 1 bottle | 53041-664-77 | Guardian Drug | 7 May 2020 |
| 500 capsule in 1 bottle | 50228-363-05 | ScieGen Pharmaceuticals | 6 December 2016 |
| 30 capsule in 1 bottle | 50228-363-30 | ScieGen Pharmaceuticals | 6 December 2016 |
| 15 capsule in 1 bottle | 85509-1031-1 | Phoenix RX | 30 July 2025 |
| 30 capsule in 1 bottle | 85509-1031-3 | Phoenix RX | 30 July 2025 |
| 60 capsule in 1 bottle | 85509-1031-6 | Phoenix RX | 30 July 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 June 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Omeprazole and Sodium bicarbonate
Clinical summary
Omeprazole and Sodium bicarbonate is a fixed-dose combination medicine indicated in adults for the short-term treatment of active duodenal ulcer, among other approved uses. MedsAcross supplies Omeprazole and Sodium bicarbonate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Omeprazole and Sodium bicarbonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZEGERID prescribing information (Santarus) · U.S. National Library of Medicine, DailyMed
Need Omeprazole and Sodium bicarbonate 20 mg/1100 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.