Medicine
Esomeprazole and Naproxen 20 mg/375 mg delayed-release tablet
Esomeprazole and Naproxen 20 mg/375 mg delayed-release tablet is a generic prescription medicine for oral use, made by 6 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°-25°C (68°-77°F),. Store in the original container and keep the…
Key facts
- Active ingredient (INN)
- Esomeprazole and Naproxen
- Brand
- Sold under the generic name
- Strength
- 20 mg/375 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 60 tablets, 1000 tablets, 30 tablets and 12 more
- Manufacturers
- Ajanta PharmaIndiaDr. Reddy's LaboratoriesIndiaAsclemedPreferred PharmaceuticalsScieGen PharmaceuticalsPhoenix RX
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F),. Store in the original container and keep the bottle tightly closed to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M01AE52 Esomeprazole and Naproxen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 February 2020
- Identifiers
- RxCUI 994005, 994008DailyMed set ID 7b3af5a8-0c92-43f4-af13-7a47dca20e92, 167340c2-1234-4d00-b4e2-cccf3d270fda, 65b892f2-8385-4bb0-8121-a58b01e8d13d +4NDC 76420-890, 50228-437, 68788-4166 +4Application ANDA204206, ANDA217738, ANDA213699
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 |
|---|---|---|---|
| 60 tablet, delayed release in 1 bottle | 27241-202-60 | Ajanta PharmaIndia | 6 October 2022 |
| 60 tablet, delayed release in 1 bottle | 55111-289-60 | Dr. Reddy's LaboratoriesIndia | 18 February 2020 |
| 1000 tablet, delayed release in 1 bottle | 50228-437-10 | ScieGen Pharmaceuticals | 11 October 2023 |
| 30 tablet, delayed release in 1 bottle | 50228-437-30 | ScieGen Pharmaceuticals | 11 October 2023 |
| 60 tablet, delayed release in 1 bottle | 50228-437-60 | ScieGen Pharmaceuticals | 12 March 2024 |
| 30 tablet, delayed release in 1 bottle | 68788-4166-3 | Preferred Pharmaceuticals | 23 July 2026 |
| 60 tablet, delayed release in 1 bottle | 68788-4166-6 | Preferred Pharmaceuticals | 23 July 2026 |
| 30 tablet, delayed release in 1 bottle | 68788-8906-3 | Preferred Pharmaceuticals | 31 July 2025 |
| 60 tablet, delayed release in 1 bottle | 68788-8906-6 | Preferred Pharmaceuticals | 31 July 2025 |
| 100 tablet, delayed release in 1 bottle | 76420-890-01 | Asclemed | 28 December 2024 |
| 30 tablet, delayed release in 1 bottle | 76420-890-30 | Asclemed | 28 December 2024 |
| 60 tablet, delayed release in 1 bottle | 76420-890-60 | Asclemed | 28 December 2024 |
| 90 tablet, delayed release in 1 bottle | 76420-890-90 | Asclemed | 28 December 2024 |
| 30 tablet, delayed release in 1 bottle | 85509-1202-3 | Phoenix RX | 21 July 2025 |
| 60 tablet, delayed release in 1 bottle | 85509-1202-6 | Phoenix RX | 21 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 30 April 2010 | 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 Esomeprazole and Naproxen
Clinical summary
Esomeprazole and Naproxen is a fixed-dose combination of a nonsteroidal anti-inflammatory drug and a proton pump inhibitor indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg. MedsAcross supplies Esomeprazole and Naproxen 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 Esomeprazole and NaproxenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Naproxen and esomeprazole magnesium prescribing information (Ajanta Pharma) · U.S. National Library of Medicine, DailyMed
Need Esomeprazole and Naproxen 20 mg/375 mg delayed-release tablet 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.