Medicine
Naproxen 500 mg tablet
Naproxen 500 mg tablet is a generic prescription medicine for oral use, made by 38 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Naproxen
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 307 more
- Manufacturers
- Granules IndiaIndiaMarksans PharmaIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaCiplaIndiaTime Cap LaboratoriesIndiaBPS WholesaleAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkExelan Pharmaceuticals38 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- 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 July 2007
- Identifiers
- RxCUI 198014, 311915, 603103 +4DailyMed set ID af9aa7a0-e287-5935-e053-2995a90a1d11, 43912294-77c9-eda8-e063-6394a90adf0a, 2ae474dd-eaae-4401-8d42-613d672daea0 +37NDC 80425-0050, 85509-1436, 42494-454 +37Application ANDA078250, ANDA212517, ANDA091432 +5
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 38 labelers. The register lists 310 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 62207-747-43 | Granules IndiaIndia | 15 April 2021 |
| 500 tablet in 1 bottle | 62207-747-47 | Granules IndiaIndia | 15 April 2021 |
| 1000 tablet in 1 bottle | 62207-747-49 | Granules IndiaIndia | 15 April 2021 |
| 100 tablet in 1 bottle | 70010-139-01 | Granules IndiaIndia | 15 April 2021 |
| 500 tablet in 1 bottle | 70010-139-05 | Granules IndiaIndia | 15 April 2021 |
| 1000 tablet in 1 bottle | 70010-139-10 | Granules IndiaIndia | 15 April 2021 |
| 100 tablet in 1 bottle | 65862-522-01 | Aurobindo PharmaIndia | 8 November 2011 |
| 500 tablet in 1 bottle | 65862-522-05 | Aurobindo PharmaIndia | 8 November 2011 |
| 2500 tablet in 1 bottle | 65862-522-26 | Aurobindo PharmaIndia | 8 November 2011 |
| 100 tablet in 1 bottle | 69097-855-07 | CiplaIndia | 5 July 2016 |
| 500 tablet in 1 bottle | 69097-855-12 | CiplaIndia | 5 July 2016 |
| 100 tablet in 1 bottle | 68462-190-01 | Glenmark PharmaceuticalsIndia | 1 July 2007 |
| 500 tablet in 1 bottle | 68462-190-05 | Glenmark PharmaceuticalsIndia | 1 July 2007 |
| 30 tablet in 1 bottle | 68462-190-30 | Glenmark PharmaceuticalsIndia | 1 July 2007 |
| 50 tablet in 1 bottle | 68462-190-50 | Glenmark PharmaceuticalsIndia | 1 July 2007 |
| 30 tablet in 1 bottle | 25000-140-03 | Marksans PharmaIndia | 28 February 2011 |
| 1000 tablet in 1 bottle | 25000-140-14 | Marksans PharmaIndia | 28 February 2011 |
| 4 bag in 1 box / 3500 tablet in 1 bag | 25000-140-19 | Marksans PharmaIndia | 28 February 2011 |
| 6 bag in 1 box / 3500 tablet in 1 bag | 25000-140-29 | Marksans PharmaIndia | 28 February 2011 |
| 1 bag in 1 box / 18975 tablet in 1 bag | 25000-140-98 | Marksans PharmaIndia | 28 February 2011 |
| 100 tablet in 1 bottle, plastic | 49483-618-01 | Time Cap LaboratoriesIndia | 6 July 2016 |
| 500 tablet in 1 bottle, plastic | 49483-618-50 | Time Cap LaboratoriesIndia | 6 July 2016 |
| 100 tablet in 1 bottle | 65162-190-10 | Amneal Pharmaceuticals | 18 February 2010 |
| 1000 tablet in 1 bottle | 65162-190-11 | Amneal Pharmaceuticals | 18 February 2010 |
| 500 tablet in 1 bottle | 65162-190-50 | Amneal Pharmaceuticals | 18 February 2010 |
| 100 tablet in 1 bottle | 53746-190-01 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 500 tablet in 1 bottle | 53746-190-05 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 1000 tablet in 1 bottle | 53746-190-10 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 14 tablet in 1 blister pack | 83209-190-14 | BPS Wholesale | 23 August 2024 |
| 15 tablet in 1 blister pack | 83209-190-15 | BPS Wholesale | 23 August 2024 |
| 18 tablet in 1 blister pack | 83209-190-18 | BPS Wholesale | 23 August 2024 |
| 20 tablet in 1 blister pack | 83209-190-20 | BPS Wholesale | 23 August 2024 |
| 28 tablet in 1 blister pack | 83209-190-28 | BPS Wholesale | 23 August 2024 |
| 30 tablet in 1 blister pack | 83209-190-30 | BPS Wholesale | 23 August 2024 |
| 60 tablet in 1 blister pack | 83209-190-60 | BPS Wholesale | 23 August 2024 |
| 100 tablet in 1 bottle, plastic | 42494-454-10 | Cameron Pharmaceuticals | 26 September 2023 |
| 100 tablet in 1 bottle | 76282-342-01 | Exelan Pharmaceuticals | 10 June 2016 |
| 500 tablet in 1 bottle | 76282-342-05 | Exelan Pharmaceuticals | 10 June 2016 |
| 60 tablet in 1 bottle | 82461-711-60 | Medcore | 30 October 2025 |
| 100 tablet in 1 bottle | 77771-436-01 | Radha Pharmaceuticals | 4 June 2021 |
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 500 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.