Medicine
Diclofenac 50 mg delayed-release tablet
Diclofenac 50 mg delayed-release tablet is a generic prescription medicine for oral use, made by 24 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 100 tablets, 60 tablets, 1000 tablets and 139 more
- Manufacturers
- Umedica LaboratoriesIndiaAurobindo PharmaIndiaA-S Medication SolutionsCarlsbad TechnologyAdvagen PharmaRising Pharma HoldingsActavis Pharma24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture.
- 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
- 26 March 1996
- Identifiers
- RxCUI 855664, 855906, 855926DailyMed set ID 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8, 0cefb675-c54e-44eb-b35c-38354b77eddd, c1d87003-f54b-4381-9e11-1c39ea2d9eb3 +37NDC 76420-572, 50090-7881, 60429-421 +37Application ANDA090066, ANDA075185, ANDA074514 +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
A sample of 40 packs from 24 labelers. The register lists 142 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, delayed release in 1 bottle | 59651-842-01 | Aurobindo PharmaIndia | 17 April 2025 |
| 60 tablet, delayed release in 1 bottle | 59651-842-60 | Aurobindo PharmaIndia | 17 April 2025 |
| 1000 tablet, delayed release in 1 bottle | 59651-842-99 | Aurobindo PharmaIndia | 17 April 2025 |
| 60 tablet, delayed release in 1 bottle | 60290-083-01 | Umedica LaboratoriesIndia | 15 February 2026 |
| 100 tablet, delayed release in 1 bottle | 60290-083-02 | Umedica LaboratoriesIndia | 15 February 2026 |
| 500 tablet, delayed release in 1 bottle | 60290-083-03 | Umedica LaboratoriesIndia | 15 February 2026 |
| 1000 tablet, delayed release in 1 bottle | 60290-083-04 | Umedica LaboratoriesIndia | 15 February 2026 |
| 24 bottle, plastic in 1 box / 100 tablet, delayed release in 1 bottle, plastic | 61442-102-01 | Carlsbad Technology | 13 November 1998 |
| 12 bottle, plastic in 1 box / 1000 tablet, delayed release in 1 bottle, plastic | 61442-102-10 | Carlsbad Technology | 13 November 1998 |
| 24 bottle, plastic in 1 box / 60 tablet, delayed release in 1 bottle, plastic | 61442-102-60 | Carlsbad Technology | 13 November 1998 |
| 24 bottle, plastic in 1 box / 100 tablet, delayed release in 1 bottle, plastic | 61442-226-01 | Carlsbad Technology | 28 March 2025 |
| 12 bottle, plastic in 1 box / 1000 tablet, delayed release in 1 bottle, plastic | 61442-226-10 | Carlsbad Technology | 28 March 2025 |
| 24 bottle, plastic in 1 box / 60 tablet, delayed release in 1 bottle, plastic | 61442-226-60 | Carlsbad Technology | 28 March 2025 |
| 100 tablet, delayed release in 1 bottle | 0228-2550-11 | Actavis Pharma | 26 March 1996 |
| 1000 tablet, delayed release in 1 bottle | 0228-2550-96 | Actavis Pharma | 26 March 1996 |
| 1000 tablet, delayed release in 1 bottle | 72888-110-00 | Advagen Pharma | 27 September 2023 |
| 100 tablet, delayed release in 1 bottle | 72888-110-01 | Advagen Pharma | 1 June 2023 |
| 500 tablet, delayed release in 1 bottle | 72888-110-05 | Advagen Pharma | 1 August 2023 |
| 30 tablet, delayed release in 1 bottle | 72888-110-30 | Advagen Pharma | 1 June 2023 |
| 60 tablet, delayed release in 1 bottle | 72888-110-60 | Advagen Pharma | 1 June 2023 |
| 60 tablet, delayed release in 1 bottle | 16571-202-06 | Rising Pharma Holdings | 31 December 2010 |
| 100 tablet, delayed release in 1 bottle | 16571-202-10 | Rising Pharma Holdings | 31 December 2010 |
| 1000 tablet, delayed release in 1 bottle | 16571-202-11 | Rising Pharma Holdings | 31 December 2010 |
| 100 tablet, delayed release in 1 bottle | 50090-0538-0 | A-S Medication Solutions | 28 November 2014 |
| 30 tablet, delayed release in 1 bottle | 50090-0538-2 | A-S Medication Solutions | 29 June 2016 |
| 90 tablet, delayed release in 1 bottle | 50090-0538-5 | A-S Medication Solutions | 29 June 2016 |
| 14 tablet, delayed release in 1 bottle | 50090-0539-1 | A-S Medication Solutions | 28 November 2014 |
| 100 tablet, delayed release in 1 bottle | 50090-0540-0 | A-S Medication Solutions | 28 November 2014 |
| 30 tablet, delayed release in 1 bottle | 50090-0540-2 | A-S Medication Solutions | 28 November 2014 |
| 90 tablet, delayed release in 1 bottle | 50090-0540-5 | A-S Medication Solutions | 28 March 2022 |
| 30 tablet, delayed release in 1 bottle | 50090-0541-0 | A-S Medication Solutions | 28 November 2014 |
| 14 tablet, delayed release in 1 bottle | 50090-0541-1 | A-S Medication Solutions | 28 November 2014 |
| 100 tablet, delayed release in 1 bottle | 50090-0542-0 | A-S Medication Solutions | 28 November 2014 |
| 30 tablet, delayed release in 1 bottle | 50090-0542-2 | A-S Medication Solutions | 28 November 2014 |
| 90 tablet, delayed release in 1 bottle | 50090-0542-5 | A-S Medication Solutions | 20 July 2015 |
| 30 tablet, delayed release in 1 bottle | 50090-0543-0 | A-S Medication Solutions | 28 November 2014 |
| 14 tablet, delayed release in 1 bottle | 50090-0543-1 | A-S Medication Solutions | 28 November 2014 |
| 14 tablet, delayed release in 1 bottle | 50090-7880-1 | A-S Medication Solutions | 4 February 2026 |
| 100 tablet, delayed release in 1 bottle | 50090-7881-0 | A-S Medication Solutions | 4 February 2026 |
| 30 tablet, delayed release in 1 bottle | 50090-7881-2 | A-S Medication Solutions | 4 February 2026 |
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 delayed-release 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.