Medicine
Prilosec 10 mg delayed-release granules
Prilosec 10 mg delayed-release granules is a prescription medicine containing Omeprazole for oral use, marketed by Covis Pharma, 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 PRILOSEC for delayed-release oral suspension at 25°C (77°F), excursions…
Key facts
- Active ingredient (INN)
- Omeprazole
- Brand
- Prilosec
- Strength
- 10 mg
- Dosage form
- Delayed-release granules
- Route
- Oral
- Packs
- 30 granule
- Marketing authorisation holder
- Covis Pharma
- Manufacturer
- Covis Pharma
- Origin register
- US FDA, United States
- Storage
- Store PRILOSEC for delayed-release oral suspension at 25°C (77°F), excursions permitted to 15 – 30°C (59 – 86°F).
- 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
- 25 August 2017
- Identifiers
- RxCUI 797058, 797061, 797063 +1DailyMed set ID b6761f84-53ac-4745-a8c8-1e5427d7e179NDC 70515-610Application NDA022056
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 granule, delayed release in 1 carton | 70515-610-01 | Covis Pharma | 25 August 2017 |
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 Prilosec 10 mg delayed-release granules 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.