Medicine
Diclofenac 20 mg/g topical solution
Diclofenac 20 mg/g topical solution is a generic prescription medicine for topical use, made by 19 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
- 20 mg/g
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 112 g and 28 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurolife PharmaIndiaLupinIndiaSun Pharmaceutical IndustriesIndiaPhoenix RXPreferred PharmaceuticalsProficient RxAdvanced Rx of TennesseeAdvanced Rx Pharmacy of TennesseeAsclemed
- 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
- 9 May 2022
- Identifiers
- RxCUI 1487074DailyMed set ID 15c2cd6d-b7c2-d927-e063-6394a90aa63e, ba4677e4-00f8-44f6-a69b-e88ca28f6b2b, 53e8ad44-ff67-d3bb-e063-6394a90a524d +28NDC 72189-546, 82804-160, 87063-223 +28Application ANDA213040, ANDA208021, ANDA208098 +4
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 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 46708-487-12 | Alembic PharmaceuticalsIndia | 11 March 2025 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 62332-487-12 | Alembic PharmaceuticalsIndia | 29 November 2022 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 13107-269-47 | Aurolife PharmaIndia | 3 February 2023 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 68180-537-01 | LupinIndia | 19 February 2024 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 51672-1369-8 | Sun Pharmaceutical IndustriesIndia | 31 May 2023 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 65162-683-12 | Amneal Pharmaceuticals | 23 August 2022 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 60505-0406-3 | Apotex | 9 May 2022 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 21922-033-16 | Encube Ethicals | 14 April 2025 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 85509-1369-1 | Phoenix RX | 5 September 2025 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 85509-1406-1 | Phoenix RX | 23 October 2025 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 85509-1537-1 | Phoenix RX | 21 July 2025 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 85509-2406-1 | Phoenix RX | 14 November 2025 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 68788-8541-1 | Preferred Pharmaceuticals | 25 October 2023 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 68788-8743-1 | Preferred Pharmaceuticals | 26 September 2024 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 68788-8838-1 | Preferred Pharmaceuticals | 6 March 2025 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 82804-074-12 | Proficient Rx | 25 March 2024 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 82804-113-12 | Proficient Rx | 5 July 2024 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 82804-160-12 | Proficient Rx | 11 November 2024 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 80425-0405-1 | Advanced Rx of Tennessee | 27 June 2024 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 80425-0550-1 | Advanced Rx of Tennessee | 27 August 2025 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 80425-0335-1 | Advanced Rx Pharmacy of Tennessee | 19 May 2023 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 80425-0337-1 | Advanced Rx Pharmacy of Tennessee | 19 May 2023 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 76420-861-04 | Asclemed | 4 October 2024 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 87063-223-04 | Asclemed | 10 June 2026 |
| 112 g in 1 bottle | 72189-546-04 | Direct_Rx | 10 April 2024 |
| 112 g in 1 bottle, pump | 72189-575-04 | Direct_Rx | 16 September 2024 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 50090-7632-0 | A-S Medication Solutions | 18 August 2025 |
| 1 bottle, pump in 1 box / 112 g in 1 bottle, pump | 42291-055-12 | AvKARE | 29 August 2023 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 72162-2601-2 | Bryant Ranch Prepack | 17 February 2026 |
| 1 bottle in 1 carton / 112 g in 1 bottle | 72603-207-01 | NorthStar Rx | 1 June 2024 |
| 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump | 83008-019-12 | Quality Care Products | 2 May 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
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 20 mg/g topical solution 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.