Medicine
Fluocinonide 0.05% cream
Fluocinonide 0.05% cream is a generic prescription medicine for topical use, made by 8 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)
- Fluocinonide
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 15 g, 30 g and 33 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaCosette PharmaceuticalsTeva PharmaceuticalsA-S Medication SolutionsAmneal Pharmaceuticals NYEncube EthicalsNuCare Pharmaceuticals,IncPreferred Pharmaceuticals
- 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
- C05AA11 Fluocinonide
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 January 1989
- Identifiers
- RxCUI 103456, 103457, 310362 +1DailyMed set ID a2e8aa7a-8996-4dc8-a36b-e8c29fb8540e, 51cbe73c-e5d6-1e6a-e054-00144ff88e88, b0bc89a9-c9d5-4adb-9785-2d4487c4c656 +12NDC 50090-3277, 66267-973, 51672-1254 +13Application ANDA071500, ANDA072488, ANDA072494 +5
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 | 51672-1254-1 | Sun Pharmaceutical IndustriesIndia | 19 January 1989 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1254-2 | Sun Pharmaceutical IndustriesIndia | 19 January 1989 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1254-3 | Sun Pharmaceutical IndustriesIndia | 19 January 1989 |
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1386-1 | Sun Pharmaceutical IndustriesIndia | 27 October 2016 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1386-2 | Sun Pharmaceutical IndustriesIndia | 27 October 2016 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1386-3 | Sun Pharmaceutical IndustriesIndia | 27 October 2016 |
| 1 tube in 1 carton / 120 g in 1 tube | 51672-1386-4 | Sun Pharmaceutical IndustriesIndia | 27 October 2016 |
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0663-15 | Cosette Pharmaceuticals | 16 November 2022 |
| 1 tube in 1 carton / 30 g in 1 tube | 0713-0663-31 | Cosette Pharmaceuticals | 16 November 2022 |
| 1 tube in 1 carton / 60 g in 1 tube | 0713-0663-60 | Cosette Pharmaceuticals | 16 November 2022 |
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0664-15 | Cosette Pharmaceuticals | 9 October 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 0713-0664-31 | Cosette Pharmaceuticals | 9 October 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 0713-0664-60 | Cosette Pharmaceuticals | 9 October 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 0093-0262-15 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 30 g in 1 tube | 0093-0262-30 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 60 g in 1 tube | 0093-0262-92 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 15 g in 1 tube | 0093-0263-15 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 30 g in 1 tube | 0093-0263-30 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 60 g in 1 tube | 0093-0263-92 | Teva Pharmaceuticals | 30 September 1990 |
| 1 tube in 1 carton / 120 g in 1 tube | 69238-1534-2 | Amneal Pharmaceuticals NY | 1 October 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 69238-1534-3 | Amneal Pharmaceuticals NY | 1 October 2017 |
| 1 tube in 1 carton / 15 g in 1 tube | 69238-1534-5 | Amneal Pharmaceuticals NY | 1 October 2017 |
| 1 tube in 1 carton / 60 g in 1 tube | 69238-1534-6 | Amneal Pharmaceuticals NY | 1 October 2017 |
| 1 tube in 1 carton / 120 g in 1 tube | 21922-064-03 | Encube Ethicals | 17 September 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-064-04 | Encube Ethicals | 17 September 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 21922-064-05 | Encube Ethicals | 25 February 2025 |
| 1 tube in 1 carton / 60 g in 1 tube | 21922-064-07 | Encube Ethicals | 25 February 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 50090-1784-0 | A-S Medication Solutions | 17 April 2015 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-3277-0 | A-S Medication Solutions | 22 November 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 50090-6309-0 | A-S Medication Solutions | 3 January 2023 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-7923-0 | A-S Medication Solutions | 4 March 2026 |
| 15 g in 1 box | 66267-973-15 | NuCare Pharmaceuticals | 12 June 2017 |
| 1 tube in 1 carton / 15 g in 1 tube | 68071-4219-5 | NuCare Pharmaceuticals | 8 January 2018 |
| 30 g in 1 tube | 68071-4921-5 | NuCare Pharmaceuticals,Inc | 7 June 2019 |
| 30 g in 1 tube | 68788-8593-3 | Preferred Pharmaceuticals | 23 February 2024 |
| 1 tube in 1 carton / 60 g in 1 tube | 68788-8593-6 | Preferred Pharmaceuticals | 23 February 2024 |
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% cream 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.