Medicine
Omeprazole 10 mg delayed-release capsule
Omeprazole 10 mg delayed-release capsule is a generic prescription medicine for oral use, made by 16 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 omeprazole delayed-release capsules in a tight container protected from…
Key facts
- Active ingredient (INN)
- Omeprazole
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 30 capsules and 71 more
- Manufacturers
- Zydus LifesciencesIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaSandozChartwell RXApotexLannett16 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store omeprazole delayed-release capsules in a tight container protected from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BC01 Omeprazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 January 2003
- Identifiers
- RxCUI 198051, 199119, 200329DailyMed set ID 0c6e00a2-31e8-4e84-928d-80e69a5fc634, 10f5502a-2e63-4f2a-a3ba-ddc5bd403051, 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 +23NDC 31722-527, 62135-530, 76420-878 +23Application ANDA204012, ANDA075410, ANDA091672 +7
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
A sample of 40 packs from 16 labelers. The register lists 74 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, delayed release in 1 bottle | 55111-157-01 | Dr. Reddy's LaboratoriesIndia | 21 January 2009 |
| 1000 capsule, delayed release in 1 bottle | 55111-157-10 | Dr. Reddy's LaboratoriesIndia | 21 January 2009 |
| 30 capsule, delayed release in 1 bottle | 55111-157-30 | Dr. Reddy's LaboratoriesIndia | 21 January 2009 |
| 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 55111-157-78 | Dr. Reddy's LaboratoriesIndia | 21 January 2009 |
| 100 capsule, delayed release in 1 bottle | 55111-643-01 | Dr. Reddy's LaboratoriesIndia | 9 March 2026 |
| 500 capsule, delayed release in 1 bottle | 55111-643-05 | Dr. Reddy's LaboratoriesIndia | 1 March 2014 |
| 30 capsule, delayed release in 1 bottle | 55111-643-30 | Dr. Reddy's LaboratoriesIndia | 9 March 2026 |
| 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 55111-643-78 | Dr. Reddy's LaboratoriesIndia | 1 March 2014 |
| 100 capsule, delayed release in 1 bottle | 65841-759-01 | Zydus LifesciencesIndia | 23 November 2012 |
| 500 capsule, delayed release in 1 bottle | 65841-759-05 | Zydus LifesciencesIndia | 23 November 2012 |
| 30 capsule, delayed release in 1 bottle | 65841-759-06 | Zydus LifesciencesIndia | 23 November 2012 |
| 1000 capsule, delayed release in 1 bottle | 65841-759-10 | Zydus LifesciencesIndia | 23 November 2012 |
| 90 capsule, delayed release in 1 bottle | 65841-759-16 | Zydus LifesciencesIndia | 23 November 2012 |
| 100 capsule, delayed release in 1 bottle | 68382-411-01 | Zydus LifesciencesIndia | 23 November 2012 |
| 500 capsule, delayed release in 1 bottle | 68382-411-05 | Zydus LifesciencesIndia | 23 November 2012 |
| 30 capsule, delayed release in 1 bottle | 68382-411-06 | Zydus LifesciencesIndia | 23 November 2012 |
| 1000 capsule, delayed release in 1 bottle | 68382-411-10 | Zydus LifesciencesIndia | 23 November 2012 |
| 90 capsule, delayed release in 1 bottle | 68382-411-16 | Zydus LifesciencesIndia | 23 November 2012 |
| 100 capsule, delayed release in 1 bottle | 59651-001-01 | Aurobindo PharmaIndia | 19 August 2015 |
| 3 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 59651-001-03 | Aurobindo PharmaIndia | 19 August 2015 |
| 30 capsule, delayed release in 1 bottle | 59651-001-30 | Aurobindo PharmaIndia | 19 August 2015 |
| 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 59651-001-78 | Aurobindo PharmaIndia | 19 August 2015 |
| 1000 capsule, delayed release in 1 bottle | 59651-001-99 | Aurobindo PharmaIndia | 19 August 2015 |
| 100 capsule, delayed release in 1 bottle | 31722-527-01 | Camber PharmaceuticalsIndia | 26 September 2019 |
| 30 capsule, delayed release in 1 bottle | 31722-527-30 | Camber PharmaceuticalsIndia | 26 September 2019 |
| 100 capsule, delayed release in 1 bottle | 68462-395-01 | Glenmark PharmaceuticalsIndia | 1 October 2016 |
| 30 capsule, delayed release in 1 bottle | 68462-395-30 | Glenmark PharmaceuticalsIndia | 1 October 2016 |
| 90 capsule, delayed release in 1 bottle | 68462-395-90 | Glenmark PharmaceuticalsIndia | 1 October 2016 |
| 30 capsule, delayed release in 1 bottle | 62135-530-30 | Chartwell RX | 16 March 2023 |
| 90 capsule, delayed release in 1 bottle | 62135-530-90 | Chartwell RX | 16 March 2023 |
| 30 capsule, delayed release in 1 bottle | 62135-559-30 | Chartwell RX | 11 February 2025 |
| 100 capsule, delayed release in 1 bottle | 0781-2785-01 | Sandoz | 28 January 2003 |
| 1000 capsule, delayed release in 1 bottle | 0781-2785-10 | Sandoz | 28 January 2003 |
| 30 capsule, delayed release in 1 bottle | 0781-2785-31 | Sandoz | 28 January 2003 |
| 100 capsule, delayed release in 1 bottle | 0781-2859-01 | Sandoz | 1 August 2019 |
| 1000 capsule, delayed release in 1 bottle | 0781-2859-10 | Sandoz | 1 August 2019 |
| 30 capsule, delayed release in 1 bottle | 0781-2859-31 | Sandoz | 1 August 2019 |
| 90 capsule, delayed release in 1 bottle | 0781-2859-92 | Sandoz | 1 July 2019 |
| 100 capsule, delayed release in 1 bottle | 60505-0145-2 | Apotex | 11 November 2003 |
| 30 capsule, delayed release in 1 bottle | 62175-114-32 | Lannett | 3 September 2003 |
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 14 September 1989 | 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
Clinical summary
Omeprazole is a proton pump inhibitor indicated for the treatment of active duodenal ulcer in adults, among other approved uses. It is available as delayed-release capsules and delayed-release granules for oral use. MedsAcross supplies Omeprazole 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 OmeprazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prilosec prescribing information (Covis Pharma) · U.S. National Library of Medicine, DailyMed
Need Omeprazole 10 mg delayed-release 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.