Medicine
Diclofenac 25 mg delayed-release tablet
Diclofenac 25 mg delayed-release tablet is a generic prescription medicine for oral use, made by 9 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
- 25 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 16 more
- Manufacturers
- Umedica LaboratoriesIndiaAdvagen PharmaAsclemedCarlsbad TechnologyRising Pharma HoldingsBluePoint LaboratoriesBryant Ranch PrepackGolden State Medical SupplyNorthStar Rx
- 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
- 13 November 1998
- Identifiers
- RxCUI 855664, 855906, 855926DailyMed set ID 3330ea92-fc9d-4541-b378-be399b0995d3, 0e5c6669-390f-4c32-b9b8-13ed3c517462, c7431496-c0ef-403a-9716-92d942709b3d +6NDC 16571-203, 60290-082, 72603-600 +6Application ANDA090066, ANDA219945, ANDA216548 +1
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 |
|---|---|---|---|
| 100 tablet, delayed release in 1 bottle | 60290-082-01 | Umedica LaboratoriesIndia | 15 February 2026 |
| 1000 tablet, delayed release in 1 bottle | 72888-109-00 | Advagen Pharma | 1 June 2023 |
| 100 tablet, delayed release in 1 bottle | 72888-109-01 | Advagen Pharma | 1 June 2023 |
| 500 tablet, delayed release in 1 bottle | 72888-109-05 | Advagen Pharma | 1 August 2023 |
| 30 tablet, delayed release in 1 bottle | 72888-109-30 | Advagen Pharma | 1 June 2023 |
| 60 tablet, delayed release in 1 bottle | 72888-109-60 | Advagen Pharma | 1 June 2023 |
| 24 bottle, plastic in 1 box / 100 tablet, delayed release in 1 bottle, plastic | 61442-101-01 | Carlsbad Technology | 13 November 1998 |
| 12 bottle, plastic in 1 box / 1000 tablet, delayed release in 1 bottle, plastic | 61442-101-10 | Carlsbad Technology | 13 November 1998 |
| 24 bottle, plastic in 1 box / 60 tablet, delayed release in 1 bottle, plastic | 61442-101-60 | Carlsbad Technology | 13 November 1998 |
| 30 tablet, delayed release in 1 bottle | 16571-203-03 | Rising Pharma Holdings | 22 July 2024 |
| 100 tablet, delayed release in 1 bottle | 16571-203-10 | Rising Pharma Holdings | 31 December 2010 |
| 100 tablet, delayed release in 1 bottle | 76420-571-01 | Asclemed | 7 March 2024 |
| 30 tablet, delayed release in 1 bottle | 76420-571-30 | Asclemed | 7 March 2024 |
| 60 tablet, delayed release in 1 bottle | 76420-571-60 | Asclemed | 7 March 2024 |
| 90 tablet, delayed release in 1 bottle | 76420-571-90 | Asclemed | 7 March 2024 |
| 100 tablet, delayed release in 1 bottle | 68001-279-00 | BluePoint Laboratories | 21 December 2015 |
| 60 tablet, delayed release in 1 bottle | 63629-3726-1 | Bryant Ranch Prepack | 2 April 2024 |
| 100 tablet, delayed release in 1 bottle, plastic | 51407-536-01 | Golden State Medical Supply | 8 April 2025 |
| 100 tablet, delayed release in 1 bottle | 72603-600-01 | NorthStar Rx | 23 April 2025 |
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 25 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.