Medicine
Diclofenac 16.05 mg/mL topical solution
Diclofenac 16.05 mg/mL topical solution is a generic prescription medicine for topical use, made by 17 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), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 16.05 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 150 mL and 28 more
- Manufacturers
- Novel LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaProficient RxDirect_RxAdvanced Rx of TennesseeAsclemedA-S Medication SolutionsPhoenix RXPreferred PharmaceuticalsSOLA Pharmaceuticals17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°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
- 26 November 2014
- Identifiers
- RxCUI 857700DailyMed set ID 11e88ced-cdcf-4101-9297-c4c3dde9d089, a5b33bf7-8113-9c54-e053-2995a90a79d8, 0803345d-7811-bc21-e063-6394a90aa661 +28NDC 70512-810, 72189-273, 80425-0361 +29Application ANDA206116, ANDA204132, ANDA203818 +2
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 in 1 carton / 150 mL in 1 bottle | 40032-016-61 | Novel LaboratoriesIndia | 9 December 2015 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 51672-1358-2 | Sun Pharmaceutical IndustriesIndia | 26 November 2014 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 70512-038-05 | SOLA Pharmaceuticals | 4 June 2021 |
| 1 bottle, dropper in 1 box / 150 mL in 1 bottle, dropper | 70512-810-05 | SOLA Pharmaceuticals | 1 July 2023 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 65162-911-74 | Amneal Pharmaceuticals | 2 September 2016 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 71205-062-15 | Proficient Rx | 2 July 2018 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 71205-450-15 | Proficient Rx | 21 April 2020 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 71205-579-15 | Proficient Rx | 21 June 2021 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 71205-640-15 | Proficient Rx | 24 February 2022 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 71205-811-15 | Proficient Rx | 2 June 2023 |
| 150 mL in 1 bottle | 72189-075-05 | Direct RX | 15 May 2020 |
| 150 mL in 1 bottle | 72189-273-05 | Direct RX | 16 September 2021 |
| 150 mL in 1 carton | 72189-454-05 | Direct_Rx | 29 March 2023 |
| 150 mL in 1 bottle | 72189-527-05 | Direct_Rx | 11 December 2023 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 80425-0240-1 | Advanced Rx of Tennessee | 10 January 2023 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 80425-0361-1 | Advanced Rx of Tennessee | 18 October 2023 |
| 1 bottle, dropper in 1 box / 150 mL in 1 bottle, dropper | 80425-0368-1 | Advanced Rx of Tennessee | 28 November 2023 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 68788-7270-1 | Preferred Pharmaceuticals | 11 January 2019 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 68788-7715-1 | Preferred Pharmaceuticals | 1 June 2020 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 50090-3316-0 | A-S Medication Solutions | 28 December 2017 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 50090-6713-0 | A-S Medication Solutions | 2 October 2023 |
| 150 mL in 1 bottle | 76420-012-30 | Asclemed | 5 February 2020 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 76420-919-02 | Asclemed | 8 February 2025 |
| 1 bottle, dropper in 1 carton / 60 mL in 1 bottle, dropper | 76420-919-04 | Asclemed | 8 February 2025 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 85509-1038-1 | Phoenix RX | 1 August 2025 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 85509-1911-1 | Phoenix RX | 23 October 2025 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 80425-0237-1 | Advanced Rx Pharmacy of Tennessee | 10 January 2023 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 72162-2031-2 | Bryant Ranch Prepack | 26 May 2023 |
| 150 mL in 1 bottle, dropper | 72189-319-05 | DirectRx | 19 January 2022 |
| 1 bottle in 1 carton / 150 mL in 1 bottle | 55700-591-15 | Quality Care Products | 9 March 2018 |
| 1 bottle, dropper in 1 carton / 150 mL in 1 bottle, dropper | 70518-2811-0 | Remedyrepack | 10 July 2020 |
| 150 mL in 1 bottle | 76420-134-05 | — | 21 January 2021 |
| 150 mL in 1 bottle | 63187-791-15 | — | 1 December 2016 |
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 16.05 mg/mL topical solution.
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 16.05 mg/mL 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.