Medicine
Diclofenac 3% gel
Diclofenac 3% gel is a generic prescription medicine for topical use, made by 16 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
Avoid freezing. Store at 20° to 25°C (68° to 77°F). Protect from heat.
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 3%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube, 100 g, 1 g and 36 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaAsclemedProficient RxAdvanced Rx Pharmacy of TennesseePreferred PharmaceuticalsDirect_RxNuCare Pharmaceuticals,IncRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. Store at 20° to 25°C (68° to 77°F). Protect from heat.
- 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
- 21 November 2013
- Identifiers
- RxCUI 855642DailyMed set ID 946b3799-2d56-12a5-e053-2a95a90aeba0, fc0c9cfe-998b-d22a-e053-6294a90afa42, 5d0a4b41-afbf-45e7-bb1c-587d72314ee0 +35NDC 72189-040, 72189-473, 68788-9435 +35Application ANDA206298, ANDA212351, ANDA208301 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 100 g in 1 tube | 46708-581-31 | Alembic PharmaceuticalsIndia | 4 March 2025 |
| 1 tube in 1 carton / 100 g in 1 tube | 62332-581-31 | Alembic PharmaceuticalsIndia | 15 September 2022 |
| 1 tube in 1 carton / 100 g in 1 tube | 68462-355-94 | Glenmark PharmaceuticalsIndia | 13 September 2016 |
| 1 tube in 1 carton / 50 g in 1 tube | 51672-1363-3 | Sun Pharmaceutical IndustriesIndia | 28 April 2016 |
| 1 tube in 1 carton / 100 g in 1 tube | 51672-1363-7 | Sun Pharmaceutical IndustriesIndia | 28 April 2016 |
| 1 tube in 1 carton / 100 g in 1 tube | 0472-1783-10 | Actavis Pharma | 19 May 2016 |
| 1 tube in 1 carton / 100 g in 1 tube | 45802-111-01 | Padagis Israel Pharmaceuticals | 27 November 2018 |
| 100 g in 1 tube | 76420-025-01 | Asclemed | 17 June 2020 |
| 100 g in 1 tube | 76420-132-01 | Asclemed | 30 October 2020 |
| 1 tube in 1 carton / 100 g in 1 tube | 76420-261-01 | Asclemed | 24 August 2022 |
| 100 g in 1 tube | 76420-275-01 | Asclemed | 9 September 2022 |
| 1 tube in 1 carton / 100 g in 1 tube | 87063-165-01 | Asclemed | 10 April 2026 |
| 1 tube in 1 carton / 100 g in 1 tube | 71205-538-00 | Proficient Rx | 24 February 2021 |
| 1 tube in 1 carton / 100 g in 1 tube | 71205-692-00 | Proficient Rx | 30 August 2022 |
| 1 tube in 1 carton / 100 g in 1 tube | 71205-752-00 | Proficient Rx | 2 February 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 82804-052-00 | Proficient Rx | 27 December 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 82804-250-00 | Proficient Rx | 23 October 2025 |
| 1 tube in 1 carton / 100 g in 1 tube | 80425-0234-1 | Advanced Rx Pharmacy of Tennessee | 9 January 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 80425-0235-1 | Advanced Rx Pharmacy of Tennessee | 10 January 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 80425-0236-1 | Advanced Rx Pharmacy of Tennessee | 9 January 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 80425-0338-1 | Advanced Rx Pharmacy of Tennessee | 19 May 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 68788-4118-1 | Preferred Pharmaceuticals | 7 July 2026 |
| 1 tube in 1 carton / 100 g in 1 tube | 68788-8236-1 | Preferred Pharmaceuticals | 9 August 2022 |
| 1 tube in 1 carton / 100 g in 1 tube | 68788-8456-1 | Preferred Pharmaceuticals | 8 June 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 68788-9435-1 | Preferred Pharmaceuticals | 8 June 2018 |
| 1 g in 1 tube | 72189-040-01 | Direct_Rx | 8 October 2019 |
| 1 g in 1 tube | 72189-379-01 | Direct_Rx | 8 September 2022 |
| 1 g in 1 tube | 72189-473-01 | Direct_Rx | 19 May 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 68071-3516-1 | NuCare Pharmaceuticals,Inc | 29 September 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 68071-3688-1 | NuCare Pharmaceuticals,Inc | 25 September 2024 |
| 100 g in 1 box | 68071-4859-1 | NuCare Pharmaceuticals,Inc | 22 April 2019 |
| 1 tube in 1 carton / 100 g in 1 tube | 70518-2526-0 | Remedyrepack | 6 January 2020 |
| 1 tube in 1 carton / 100 g in 1 tube | 70518-3315-0 | Remedyrepack | 28 December 2021 |
| 1 tube in 1 carton / 100 g in 1 tube | 70518-3779-0 | Remedyrepack | 7 July 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 63629-2526-1 | Bryant Ranch Prepack | 27 November 2018 |
| 1 tube in 1 carton / 100 g in 1 tube | 72162-1391-1 | Bryant Ranch Prepack | 27 November 2018 |
| 1 tube in 1 carton / 100 g in 1 tube | 85534-0089-0 | Hawaii Repack | 12 July 2026 |
| 100 g in 1 tube | 45865-260-01 | Medsource Pharmaceuticals | 7 July 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 85509-1581-1 | Phoenix RX | 21 July 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 3% gel 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.