Medicine
Naproxen 125 mg/5 mL oral suspension
Naproxen 125 mg/5 mL oral suspension 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° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Naproxen
- Brand
- Sold under the generic name
- Strength
- 125 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle, 500 mL, 473 mL and 3 more
- Manufacturers
- Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaAcella PharmaceuticalsAmneal Pharmaceuticals NYANI PharmaceuticalsHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Avoid excessive heat above 40°C (104°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
- 3 August 2020
- Identifiers
- RxCUI 311913DailyMed set ID fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd, a5757b1a-62c9-4421-9794-6fb121ce9b7e, 252726a7-757a-4b97-b5b8-ffff4ac1d103 +3NDC 31722-682, 0054-3630, 70954-151 +3Application ANDA215776, ANDA074190, ANDA211910 +3
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 473 mL in 1 bottle | 59651-528-47 | Aurobindo PharmaIndia | 3 October 2025 |
| 500 mL in 1 bottle | 31722-682-05 | Camber PharmaceuticalsIndia | 7 June 2022 |
| 473 mL in 1 bottle | 42192-619-16 | Acella Pharmaceuticals | 12 November 2020 |
| 473 mL in 1 bottle | 69238-1730-2 | Amneal Pharmaceuticals NY | 3 August 2020 |
| 500 mL in 1 bottle | 70954-151-10 | ANI Pharmaceuticals | 12 March 2021 |
| 500 mL in 1 bottle, plastic | 0054-3630-63 | Hikma Pharmaceuticals | 24 February 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 125 mg/5 mL oral suspension 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.