Medicine
Fluocinolone acetonide 0.1 mg/mL topical solution
Fluocinolone acetonide 0.1 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
Protect from freezing. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Fluocinolone acetonide
- Brand
- Sold under the generic name
- Strength
- 0.1 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 60 mL and 5 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaLupinIndiaBryant Ranch PrepackActavis PharmaEncube EthicalsFougera Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. 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
- C05AA10 Fluocinolone acetonide
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 December 1982
- Identifiers
- RxCUI 1191310DailyMed set ID 02352ed1-3568-441f-add8-45201351a11c, 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36, 460f5a55-6437-4651-bc08-8063ca579c8d +4NDC 51672-1365, 21922-003, 43386-069 +4Application ANDA089124, ANDA209913, ANDA206422 +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 / 60 mL in 1 bottle | 43386-069-60 | LupinIndia | 2 September 2015 |
| 1 bottle in 1 carton / 20 mL in 1 bottle | 51672-1365-2 | Sun Pharmaceutical IndustriesIndia | 27 March 2015 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 51672-1365-4 | Sun Pharmaceutical IndustriesIndia | 27 March 2015 |
| 1 bottle, with applicator in 1 carton / 60 mL in 1 bottle, with applicator | 0591-2990-60 | Actavis Pharma | 7 December 2016 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 21922-003-01 | Encube Ethicals | 20 March 2019 |
| 60 mL in 1 bottle | 0168-0059-60 | Fougera Pharmaceuticals | 16 December 1982 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 63629-9584-1 | Bryant Ranch Prepack | 12 December 2022 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 72162-1271-6 | Bryant Ranch Prepack | 20 March 2019 |
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.
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 Fluocinolone acetonide
Clinical summary
Fluocinolone acetonide is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available as oil, topical solution and cream for otic and intravitreal use. MedsAcross supplies Fluocinolone acetonide 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 Fluocinolone acetonideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- fluocinolone acetonide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fluocinolone acetonide 0.1 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.