Medicine
Naproxen 550 mg tablet
Naproxen 550 mg tablet is a generic prescription medicine for oral use, made by 15 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 15° to 30°C (59° to 86°F) in well-closed containers.
Key facts
- Active ingredient (INN)
- Naproxen
- Brand
- Sold under the generic name
- Strength
- 550 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 2500 tablets and 96 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaBryant Ranch PrepackScieGen Pharmaceuticals15 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 15° to 30°C (59° to 86°F) in well-closed containers.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G02CC02 Naproxen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2007
- Identifiers
- RxCUI 849431, 849398, 198012 +2DailyMed set ID 8181bb7a-d917-4388-bcb0-a74671b07b06, bee7b482-8ba5-411d-90ee-de00df50d2b7, 397db794-027c-4a89-993e-07c208b457a3 +21NDC 50090-5238, 63629-8516, 71205-479 +21Application ANDA078486, ANDA212199, ANDA200629 +1
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 15 labelers. The register lists 99 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-516-01 | Aurobindo PharmaIndia | 31 October 2011 |
| 500 tablet, film coated in 1 bottle | 65862-516-05 | Aurobindo PharmaIndia | 31 October 2011 |
| 2500 tablet, film coated in 1 bottle | 65862-516-26 | Aurobindo PharmaIndia | 31 October 2011 |
| 30 tablet, film coated in 1 bottle | 65862-516-30 | Aurobindo PharmaIndia | 31 October 2011 |
| 100 tablet, film coated in 1 bottle | 43598-495-01 | Dr. Reddy's LaboratoriesIndia | 26 April 2016 |
| 500 tablet, film coated in 1 bottle | 43598-495-05 | Dr. Reddy's LaboratoriesIndia | 26 April 2016 |
| 1000 tablet, film coated in 1 bottle | 43598-495-10 | Dr. Reddy's LaboratoriesIndia | 26 April 2016 |
| 30 tablet, film coated in 1 bottle | 43598-495-30 | Dr. Reddy's LaboratoriesIndia | 26 April 2016 |
| 100 tablet in 1 bottle | 68462-179-01 | Glenmark PharmaceuticalsIndia | 1 August 2007 |
| 500 tablet in 1 bottle | 68462-179-05 | Glenmark PharmaceuticalsIndia | 1 August 2007 |
| 100 tablet in 1 bottle | 50228-433-01 | ScieGen Pharmaceuticals | 30 October 2019 |
| 500 tablet in 1 bottle | 50228-433-05 | ScieGen Pharmaceuticals | 30 October 2019 |
| 1000 tablet in 1 bottle | 50228-433-10 | ScieGen Pharmaceuticals | 30 October 2019 |
| 30 tablet in 1 bottle | 50228-433-30 | ScieGen Pharmaceuticals | 30 October 2019 |
| 500 tablet in 1 bottle | 63629-8516-1 | Bryant Ranch Prepack | 30 October 2019 |
| 100 tablet in 1 bottle | 63629-8517-1 | Bryant Ranch Prepack | 30 October 2019 |
| 6 tablet, film coated in 1 bottle | 71335-0822-0 | Bryant Ranch Prepack | 29 January 2025 |
| 20 tablet, film coated in 1 bottle | 71335-0822-1 | Bryant Ranch Prepack | 21 February 2020 |
| 100 tablet, film coated in 1 bottle | 71335-0822-2 | Bryant Ranch Prepack | 29 January 2025 |
| 30 tablet, film coated in 1 bottle | 71335-0822-3 | Bryant Ranch Prepack | 23 August 2018 |
| 120 tablet, film coated in 1 bottle | 71335-0822-4 | Bryant Ranch Prepack | 29 May 2018 |
| 60 tablet, film coated in 1 bottle | 71335-0822-5 | Bryant Ranch Prepack | 26 April 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0822-6 | Bryant Ranch Prepack | 29 January 2025 |
| 42 tablet, film coated in 1 bottle | 71335-0822-7 | Bryant Ranch Prepack | 29 January 2025 |
| 14 tablet, film coated in 1 bottle | 71335-0822-8 | Bryant Ranch Prepack | 29 January 2025 |
| 56 tablet, film coated in 1 bottle | 71335-0822-9 | Bryant Ranch Prepack | 29 January 2025 |
| 6 tablet, film coated in 1 bottle | 71335-1650-0 | Bryant Ranch Prepack | 12 August 2024 |
| 20 tablet, film coated in 1 bottle | 71335-1650-1 | Bryant Ranch Prepack | 12 August 2024 |
| 100 tablet, film coated in 1 bottle | 71335-1650-2 | Bryant Ranch Prepack | 12 August 2024 |
| 30 tablet, film coated in 1 bottle | 71335-1650-3 | Bryant Ranch Prepack | 23 June 2020 |
| 120 tablet, film coated in 1 bottle | 71335-1650-4 | Bryant Ranch Prepack | 12 August 2024 |
| 60 tablet, film coated in 1 bottle | 71335-1650-5 | Bryant Ranch Prepack | 12 August 2024 |
| 90 tablet, film coated in 1 bottle | 71335-1650-6 | Bryant Ranch Prepack | 12 August 2024 |
| 42 tablet, film coated in 1 bottle | 71335-1650-7 | Bryant Ranch Prepack | 12 August 2024 |
| 14 tablet, film coated in 1 bottle | 71335-1650-8 | Bryant Ranch Prepack | 12 August 2024 |
| 56 tablet, film coated in 1 bottle | 71335-1650-9 | Bryant Ranch Prepack | 12 August 2024 |
| 500 tablet in 1 bottle | 71335-2294-1 | Bryant Ranch Prepack | 20 August 2026 |
| 6 tablet in 1 bottle | 71335-3075-0 | Bryant Ranch Prepack | 9 February 2026 |
| 20 tablet in 1 bottle | 71335-3075-1 | Bryant Ranch Prepack | 9 February 2026 |
| 100 tablet in 1 bottle | 71335-3075-2 | Bryant Ranch Prepack | 9 February 2026 |
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 11 March 1976 | 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 Naproxen
Clinical summary
Naproxen is a nonsteroidal anti-inflammatory drug indicated for the relief of the signs and symptoms of. It is available as tablets, delayed-release tablets and extended-release tablets for oral use. MedsAcross supplies 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 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 prescribing information (Acella Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Naproxen 550 mg 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.