Medicine
Fluocinonide 0.05% gel
Fluocinonide 0.05% gel is a generic prescription medicine for topical use, made by 2 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°- 25°C (68°- 77°F) Manufactured by Padagis®, Yeruham, Israel…
Key facts
- Active ingredient (INN)
- Fluocinonide
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 3 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°- 25°C (68°- 77°F) Manufactured by Padagis®, Yeruham, Israel www.padagis.com Rev 08-24 7D000 RC PH2
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C05AA11 Fluocinonide
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 July 1997
- Identifiers
- RxCUI 310362, 103456, 103457 +1DailyMed set ID 8e22600e-a1a2-432c-a47c-b7b99a0b1e46, b0bc89a9-c9d5-4adb-9785-2d4487c4c656NDC 45802-761, 51672-1279Application ANDA209030, ANDA074935
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 / 15 g in 1 tube | 51672-1279-1 | Sun Pharmaceutical IndustriesIndia | 29 July 1997 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1279-2 | Sun Pharmaceutical IndustriesIndia | 29 July 1997 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1279-3 | Sun Pharmaceutical IndustriesIndia | 29 July 1997 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-761-15 | Padagis Israel Pharmaceuticals | 10 April 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-761-30 | Padagis Israel Pharmaceuticals | 10 April 2025 |
| 1 tube in 1 carton / 60 g in 1 tube | 45802-761-60 | Padagis Israel Pharmaceuticals | 10 April 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 30 June 1971 | 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 Fluocinonide
Clinical summary
Fluocinonide is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available as cream, topical solution and ointment. MedsAcross supplies Fluocinonide 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 FluocinonideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fluocinonide prescribing information (Saptalis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fluocinonide 0.05% 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.