Medicine
Diclofenac 50 mg powder for oral solution
Diclofenac 50 mg powder for oral solution is a generic prescription medicine for oral use, made by 8 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 25°C (77°F). Excursions permitted from 15°C-30°C (59°F-86°F).
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 9 packets, 1 powder, 9 powder and 8 more
- Manufacturers
- Camber PharmaceuticalsIndiaUmedica LaboratoriesIndiaAscend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaTorrent PharmaceuticalsIndiaNivagen PharmaceuticalsLeading PharmaPar Health
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F). Excursions permitted from 15°C-30°C (59°F-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AX18 Diclofenac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 March 2022
- Identifiers
- RxCUI 859063DailyMed set ID 9dd418b2-4b0e-498c-b453-f580c69ddc6d, f675a627-c944-4ec6-8c08-b5fdb78dc269, 33930285-dd97-415c-9e2a-491bd7b12af9 +5NDC 69315-506, 67877-772, 60290-061 +5Application NDA022165, ANDA216635, ANDA217010 +4
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 packet in 1 carton / 1 powder, for solution in 1 packet | 67877-772-58 | Ascend LaboratoriesIndia | 24 October 2022 |
| 1 powder, for solution in 1 packet | 31722-046-31 | Camber PharmaceuticalsIndia | 4 March 2022 |
| 9 powder, for solution in 1 carton | 31722-046-32 | Camber PharmaceuticalsIndia | 4 March 2022 |
| 9 packet in 1 carton / 1 powder, for solution in 1 packet | 51672-4240-6 | Sun Pharmaceutical IndustriesIndia | 24 June 2024 |
| 9 packet in 1 carton / 1 powder, for solution in 1 packet | 13668-672-64 | Torrent PharmaceuticalsIndia | 22 January 2025 |
| 1 powder, for solution in 1 packet | 60290-061-01 | Umedica LaboratoriesIndia | 15 February 2026 |
| 9 powder, for solution in 1 carton | 60290-061-02 | Umedica LaboratoriesIndia | 15 February 2026 |
| 9 packet in 1 carton / 1 powder, for solution in 1 packet | 69315-506-09 | Leading Pharma | 20 December 2022 |
| 1 powder, for solution in 1 packet | 75834-338-01 | Nivagen Pharmaceuticals | 15 December 2025 |
| 9 powder, for solution in 1 carton | 75834-338-02 | Nivagen Pharmaceuticals | 15 December 2025 |
| 9 powder, for solution in 1 carton | 49884-905-64 | Par Health | 3 January 2023 |
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 28 July 1988 | 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 Diclofenac 50 mg powder for oral solution.
Other strengths and forms of Diclofenac
Clinical summary
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. MedsAcross supplies Diclofenac 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 DiclofenacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZIPSOR prescribing information (Assertio Specialty Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diclofenac 50 mg powder for oral solution 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.