Medicine
Ciclopirox 80 mg/mL topical solution
Ciclopirox 80 mg/mL topical solution is a generic prescription medicine for topical use, made by 6 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
Ciclopirox topical solution, 8% (nail lacquer), should be stored at 20°C to…
Key facts
- Active ingredient (INN)
- Ciclopirox
- Brand
- Sold under the generic name
- Strength
- 80 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle and 8 more
- Manufacturers
- Bryant Ranch PrepackPreferred PharmaceuticalsA-S Medication SolutionsAcella PharmaceuticalsEncube EthicalsPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Ciclopirox topical solution, 8% (nail lacquer), should be stored at 20°C to 25°C (68°F to 77°F) CAUTION: Flammable. Protect from light (e.g., store the bottle in the carton after every use).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AE14 Ciclopirox
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 September 2007
- Identifiers
- RxCUI 309291DailyMed set ID 79084b47-7481-4926-9837-e08f633b1ddf, efcd78c0-2426-4fcc-a1c8-527e4e6f99d3, 02f46b6e-b424-4210-83bf-e79618df4344 +8NDC 21922-053, 68788-6797, 45802-141 +8Application ANDA077687, ANDA077623, ANDA078172
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 / 6.6 mL in 1 bottle | 42192-715-06 | Acella Pharmaceuticals | 4 November 2019 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 21922-053-51 | Encube Ethicals | 9 November 2023 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 45802-141-67 | Padagis Israel Pharmaceuticals | 19 September 2007 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 63629-8623-1 | Bryant Ranch Prepack | 9 July 2021 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 71335-2836-1 | Bryant Ranch Prepack | 22 October 2025 |
| 1 bottle in 1 carton / 6.6 mL in 1 bottle | 72162-1321-2 | Bryant Ranch Prepack | 21 March 2024 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 72162-2076-1 | Bryant Ranch Prepack | 16 August 2023 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 72162-2298-2 | Bryant Ranch Prepack | 9 November 2023 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 68788-6797-6 | Preferred Pharmaceuticals | 3 November 2016 |
| 1 bottle, with applicator in 1 carton / 6.6 mL in 1 bottle, with applicator | 68788-8755-6 | Preferred Pharmaceuticals | 14 October 2024 |
| 1 bottle in 1 carton / 6.6 mL in 1 bottle | 50090-6562-0 | A-S Medication Solutions | 18 July 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 30 December 1982 | 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 Ciclopirox
Clinical summary
Ciclopirox is a prescription medicine indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. It is available as topical solution, cream and gel. MedsAcross supplies Ciclopirox 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 CiclopiroxFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ciclopirox prescribing information (Acella Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ciclopirox 80 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.