Medicine
Naproxen and Sumatriptan 500 mg/85 mg tablet
Naproxen and Sumatriptan 500 mg/85 mg tablet is a generic prescription medicine for oral use, made by 4 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° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Naproxen and Sumatriptan
- Brand
- Sold under the generic name
- Strength
- 500 mg/85 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 9 tablets, 30 tablets, 100 tablets and 3 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaCypress, Hawthorn, MacovenNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 May 2015
- Identifiers
- RxCUI 849450DailyMed set ID 3f2ec27e-0e96-4028-a1fa-114e6d501464, f5203c66-0a40-4263-a237-b71e930e4697, 96ed12a3-fa76-4afd-bee8-1ab19eb607f3 +1NDC 16714-891, 65862-928, 47335-410 +1Application ANDA202803, ANDA207457, NDA021926
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 |
|---|---|---|---|
| 9 tablet, film coated in 1 bottle | 65862-928-36 | Aurobindo PharmaIndia | 15 February 2018 |
| 9 tablet, film coated in 1 bottle | 47335-410-22 | Sun Pharmaceutical IndustriesIndia | 20 July 2018 |
| 30 tablet, film coated in 1 bottle | 47335-410-83 | Sun Pharmaceutical IndustriesIndia | 20 July 2018 |
| 100 tablet, film coated in 1 bottle | 47335-410-88 | Sun Pharmaceutical IndustriesIndia | 20 July 2018 |
| 9 tablet in 1 bottle | 44183-850-09 | Cypress, Hawthorn, Macoven | 15 February 2018 |
| 9 tablet, film coated in 1 bottle | 16714-891-01 | NorthStar RxLLC | 27 November 2018 |
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 15 April 2008 | 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
Alternatives
Other makers and brands of Naproxen and Sumatriptan 500 mg/85 mg tablet.
Clinical summary
Naproxen and Sumatriptan is a fixed-dose combination of a nonsteroidal anti-inflammatory drug and a serotonin-1b and serotonin-1d receptor agonist indicated for the acute treatment of migraine, among other approved uses. MedsAcross supplies Naproxen and Sumatriptan 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 Naproxen and SumatriptanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sumatriptan Succinate and Naproxen Sodium prescribing information (Cypress, Hawthorn, Macoven) · U.S. National Library of Medicine, DailyMed
Need Naproxen and Sumatriptan 500 mg/85 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.