Medicine
Fluorometholone 1 mg/mL ophthalmic suspension
Fluorometholone 1 mg/mL ophthalmic suspension is a generic prescription medicine for ophthalmic 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 2° to 25°C (36° to77°F), Protect from freezing. Store in an upright…
Key facts
- Active ingredient (INN)
- Fluorometholone
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 1 bottle and 1 more
- Manufacturers
- Amneal PharmaceuticalsSandoz
- Origin register
- US FDA, United States
- Storage
- Store at 2° to 25°C (36° to77°F), Protect from freezing. Store in an upright position.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C05AA06 Fluorometholone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 January 2023
- Identifiers
- RxCUI 310377DailyMed set ID c9cbf06e-5413-4c3c-9ded-174c856a4ce1, e7988a3b-e432-4d42-a8d2-63ca017e6a01NDC 0781-6187, 60219-1586, 60219-1585Application ANDA218819, ANDA216348
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, dropper in 1 carton / 5 mL in 1 bottle, dropper | 60219-1585-3 | Amneal Pharmaceuticals | 9 January 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 60219-1586-6 | Amneal Pharmaceuticals | 9 January 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 0781-6187-70 | Sandoz | 18 May 2026 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 0781-6187-75 | Sandoz | 18 May 2026 |
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 12 January 1972 | 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 Fluorometholone 1 mg/mL ophthalmic suspension.
Other strengths and forms of Fluorometholone
Clinical summary
Fluorometholone is a corticosteroid indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. It is available as ophthalmic suspension and eye drops. MedsAcross supplies Fluorometholone 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 FluorometholoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FML prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Fluorometholone 1 mg/mL ophthalmic suspension 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.