Medicine
Diclofenac 100 mg tablet
Diclofenac 100 mg tablet is a generic prescription medicine for oral use, made by 7 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 room temperature 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 60 tablets and 28 more
- Manufacturers
- Bryant Ranch PrepackAsclemedSportpharmAdvanced Rx of TennesseeRemedyrepackBluePoint LaboratoriesIngenus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). Protect from light and 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 September 2022
- Identifiers
- RxCUI 855657DailyMed set ID 1d4d6370-2b45-fa6d-e063-6294a90a4a67, 1a237198-ca24-4159-b570-b5a23c8e91b0, 896e3f7d-88e6-4563-b879-a2757d19fd62 +4NDC 80425-0414, 50742-278, 68001-612 +4Application ANDA216275
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, film coated in 1 bottle, plastic | 50742-278-01 | Ingenus Pharmaceuticals | 26 September 2022 |
| 30 tablet, film coated in 1 bottle, plastic | 80425-0414-1 | Advanced Rx of Tennessee | 11 July 2024 |
| 60 tablet, film coated in 1 bottle, plastic | 80425-0414-2 | Advanced Rx of Tennessee | 11 July 2024 |
| 90 tablet, film coated in 1 bottle, plastic | 80425-0414-3 | Advanced Rx of Tennessee | 11 July 2024 |
| 7 tablet, film coated in 1 bottle, plastic | 76420-598-07 | Asclemed | 2 September 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 76420-598-10 | Asclemed | 2 September 2023 |
| 14 tablet, film coated in 1 bottle, plastic | 76420-598-14 | Asclemed | 2 September 2023 |
| 20 tablet, film coated in 1 bottle, plastic | 76420-598-20 | Asclemed | 2 September 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 76420-598-30 | Asclemed | 2 September 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 76420-598-60 | Asclemed | 2 September 2023 |
| 90 tablet, film coated in 1 bottle, plastic | 76420-598-90 | Asclemed | 2 September 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 68001-612-00 | BluePoint Laboratories | 12 February 2024 |
| 100 tablet, film coated in 1 bottle, plastic | 71335-9665-0 | Bryant Ranch Prepack | 13 April 2026 |
| 60 tablet, film coated in 1 bottle, plastic | 71335-9665-1 | Bryant Ranch Prepack | 22 March 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 71335-9665-2 | Bryant Ranch Prepack | 23 March 2023 |
| 15 tablet, film coated in 1 bottle, plastic | 71335-9665-3 | Bryant Ranch Prepack | 13 April 2026 |
| 14 tablet, film coated in 1 bottle, plastic | 71335-9665-4 | Bryant Ranch Prepack | 20 March 2023 |
| 10 tablet, film coated in 1 bottle, plastic | 71335-9665-5 | Bryant Ranch Prepack | 24 September 2024 |
| 21 tablet, film coated in 1 bottle, plastic | 71335-9665-6 | Bryant Ranch Prepack | 24 January 2024 |
| 90 tablet, film coated in 1 bottle, plastic | 71335-9665-7 | Bryant Ranch Prepack | 13 April 2026 |
| 120 tablet, film coated in 1 bottle, plastic | 71335-9665-8 | Bryant Ranch Prepack | 13 April 2026 |
| 7 tablet, film coated in 1 bottle, plastic | 71335-9665-9 | Bryant Ranch Prepack | 13 April 2026 |
| 60 tablet, film coated in 1 bottle, plastic | 70518-4044-0 | Remedyrepack | 5 April 2024 |
| 30 tablet, film coated in 1 bottle, plastic | 70518-4044-1 | Remedyrepack | 13 June 2025 |
| 100 tablet, film coated in 1 bottle, plastic | 85766-032-01 | Sportpharm | 7 August 2025 |
| 7 tablet, film coated in 1 bottle, plastic | 85766-032-07 | Sportpharm | 7 August 2025 |
| 14 tablet, film coated in 1 bottle, plastic | 85766-032-14 | Sportpharm | 7 August 2025 |
| 20 tablet, film coated in 1 bottle, plastic | 85766-032-20 | Sportpharm | 7 August 2025 |
| 30 tablet, film coated in 1 bottle, plastic | 85766-032-30 | Sportpharm | 7 August 2025 |
| 60 tablet, film coated in 1 bottle, plastic | 85766-032-60 | Sportpharm | 7 August 2025 |
| 90 tablet, film coated in 1 bottle, plastic | 85766-032-90 | Sportpharm | 7 August 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 100 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.