Medicine
Diclofenac 50 mg tablet
Diclofenac 50 mg tablet is a generic prescription medicine for oral use, made by 26 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 to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 104 more
- Manufacturers
- Umedica LaboratoriesIndiaZydus LifesciencesIndiaBryant Ranch PrepackAdvagen PharmaAmici PharmaSOLA PharmaceuticalsHavix Group Inc d-b-a Aavis PharmaceuticalsTeva PharmaceuticalsAmerisynArchis Pharma26 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 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
- 11 August 1998
- Identifiers
- RxCUI 855942, 857702, 2753518DailyMed set ID e29e7aea-0bcd-46e5-b011-fbaf5aa2244a, 3fd418ac-49f6-d520-e063-6394a90afbd8, 5d37fc5a-7a2f-432e-b4e9-e00c246ce33c +36NDC 71335-2530, 85509-2750, 50090-6768 +36Application ANDA215585, ANDA215787, ANDA215750 +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
A sample of 40 packs from 26 labelers. The register lists 107 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 | 60290-057-01 | Umedica LaboratoriesIndia | 12 May 2022 |
| 1000 tablet, film coated in 1 bottle | 60290-057-02 | Umedica LaboratoriesIndia | 12 May 2022 |
| 500 tablet, film coated in 1 bottle | 60290-057-03 | Umedica LaboratoriesIndia | 12 May 2022 |
| 1000 tablet, film coated in 1 bottle | 70710-1832-0 | Zydus LifesciencesIndia | 12 May 2022 |
| 100 tablet, film coated in 1 bottle | 70710-1832-1 | Zydus LifesciencesIndia | 12 May 2022 |
| 500 tablet, film coated in 1 bottle | 70710-1832-5 | Zydus LifesciencesIndia | 12 May 2022 |
| 100 tablet, film coated in 1 bottle, plastic | 69292-550-01 | Amici Pharma | 11 December 2020 |
| 100 tablet in 1 bottle | 69292-552-01 | Amici Pharma | 12 March 2024 |
| 500 tablet in 1 bottle | 69292-552-50 | Amici Pharma | 12 March 2024 |
| 100 tablet, film coated in 1 bottle, plastic | 70512-750-10 | SOLA Pharmaceuticals | 21 October 2024 |
| 500 tablet, film coated in 1 bottle, plastic | 70512-750-50 | SOLA Pharmaceuticals | 31 December 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 70512-900-30 | SOLA Pharmaceuticals | 1 November 2024 |
| 1000 tablet, coated in 1 bottle | 72888-073-00 | Advagen Pharma | 19 December 2020 |
| 100 tablet, coated in 1 bottle | 72888-073-01 | Advagen Pharma | 19 December 2020 |
| 500 tablet, coated in 1 bottle | 72888-073-05 | Advagen Pharma | 3 February 2022 |
| 30 tablet, coated in 1 bottle | 72888-073-30 | Advagen Pharma | 19 December 2020 |
| 100 tablet in 1 bottle | 87564-011-10 | Amerisyn | 26 July 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 72819-151-10 | Archis Pharma | 15 September 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 69306-750-03 | Doc Rx | 7 November 2025 |
| 100 tablet in 1 bottle | 71337-046-01 | Havix Group Inc d-b-a Aavis Pharmaceuticals | 26 June 2023 |
| 500 tablet in 1 bottle | 71337-046-05 | Havix Group Inc d-b-a Aavis Pharmaceuticals | 26 June 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 50742-279-01 | Ingenus Pharmaceuticals | 11 October 2021 |
| 100 tablet, film coated in 1 bottle | 0093-0948-01 | Teva Pharmaceuticals | 11 August 1998 |
| 500 tablet, film coated in 1 bottle | 0093-0948-05 | Teva Pharmaceuticals | 11 August 1998 |
| 100 tablet in 1 bottle | 87528-001-10 | VICI Pharmaceuticals | 10 June 2026 |
| 20 tablet, film coated in 1 bottle | 63629-4108-1 | Bryant Ranch Prepack | 2 December 2009 |
| 90 tablet, film coated in 1 bottle | 63629-4108-2 | Bryant Ranch Prepack | 20 April 2010 |
| 30 tablet, film coated in 1 bottle | 63629-4108-3 | Bryant Ranch Prepack | 25 May 2010 |
| 60 tablet, film coated in 1 bottle | 63629-4108-4 | Bryant Ranch Prepack | 6 January 2011 |
| 45 tablet, film coated in 1 bottle | 63629-4108-5 | Bryant Ranch Prepack | 22 December 2021 |
| 58 tablet, film coated in 1 bottle | 63629-4108-6 | Bryant Ranch Prepack | 22 December 2021 |
| 18 tablet, film coated in 1 bottle | 63629-4108-7 | Bryant Ranch Prepack | 22 December 2021 |
| 120 tablet, film coated in 1 bottle | 63629-4108-8 | Bryant Ranch Prepack | 22 December 2021 |
| 20 tablet, coated in 1 bottle | 71335-2052-1 | Bryant Ranch Prepack | 18 March 2022 |
| 90 tablet, coated in 1 bottle | 71335-2052-2 | Bryant Ranch Prepack | 18 March 2022 |
| 30 tablet, coated in 1 bottle | 71335-2052-3 | Bryant Ranch Prepack | 16 March 2022 |
| 60 tablet, coated in 1 bottle | 71335-2052-4 | Bryant Ranch Prepack | 16 February 2022 |
| 45 tablet, coated in 1 bottle | 71335-2052-5 | Bryant Ranch Prepack | 18 March 2022 |
| 58 tablet, coated in 1 bottle | 71335-2052-6 | Bryant Ranch Prepack | 18 March 2022 |
| 18 tablet, coated in 1 bottle | 71335-2052-7 | Bryant Ranch Prepack | 18 March 2022 |
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
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 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.