Medicine
Diclofenac 25 mg tablet
Diclofenac 25 mg 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).
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 16 more
- Manufacturers
- Umedica LaboratoriesIndiaAdvagen PharmaCarwin Pharmaceutical AssociatesINA PharmaceuticsNivagen PharmaceuticalsTrifluent PharmaAmici PharmaCintex ServicesHappy Robin
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 16 September 2021
- Identifiers
- RxCUI 857702, 855942, 2753518DailyMed set ID 5ecd99fe-cb74-4a65-9636-2aefd2416ece, 1fa07fbe-3708-4200-b3ff-a920434896b6, 6c703075-b9a3-42de-87f6-fd1e1ef4b2e3 +7NDC 74157-007, 60290-088, 74157-016 +7Application ANDA075229, ANDA215750, ANDA215787 +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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 60290-088-01 | Umedica LaboratoriesIndia | 28 September 2024 |
| 100 tablet, film coated in 1 bottle | 60290-088-02 | Umedica LaboratoriesIndia | 28 September 2024 |
| 500 tablet, film coated in 1 bottle | 60290-088-03 | Umedica LaboratoriesIndia | 28 September 2024 |
| 1000 tablet, film coated in 1 bottle | 60290-088-04 | Umedica LaboratoriesIndia | 28 September 2024 |
| 60 tablet, film coated in 1 bottle | 60290-088-05 | Umedica LaboratoriesIndia | 30 October 2025 |
| 60 tablet, coated in 1 bottle | 74157-007-60 | INA Pharmaceutics | 20 September 2021 |
| 60 tablet in 1 bottle | 74157-016-60 | INA Pharmaceutics | 1 October 2024 |
| 1000 tablet, coated in 1 bottle | 72888-086-00 | Advagen Pharma | 16 September 2021 |
| 100 tablet, coated in 1 bottle | 72888-086-01 | Advagen Pharma | 16 September 2021 |
| 30 tablet, coated in 1 bottle | 72888-086-30 | Advagen Pharma | 16 September 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 69292-548-30 | Amici Pharma | 18 April 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 15370-185-30 | Carwin Pharmaceutical Associates | 1 November 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 15370-185-60 | Carwin Pharmaceutical Associates | 8 April 2025 |
| 60 tablet in 1 bottle | 24470-924-60 | Cintex Services | 19 December 2023 |
| 60 tablet in 1 bottle | 87127-802-60 | Happy Robin | 24 September 2025 |
| 30 tablet, film coated in 1 bottle | 75834-337-30 | Nivagen Pharmaceuticals | 10 October 2025 |
| 60 tablet, film coated in 1 bottle | 75834-337-60 | Nivagen Pharmaceuticals | 10 October 2025 |
| 30 tablet, coated in 1 bottle | 73352-086-30 | Trifluent Pharma | 17 February 2023 |
| 60 tablet, coated in 1 bottle | 73352-086-60 | Trifluent Pharma | 25 September 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 25 mg tablet.
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 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.