Medicine
Durezol 0.5 mg/mL ophthalmic emulsion
Durezol 0.5 mg/mL ophthalmic emulsion is a prescription medicine containing Difluprednate for ophthalmic use, marketed by Sandoz, 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
Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Difluprednate
- Brand
- Durezol
- Strength
- 0.5 mg/mL
- Dosage form
- Ophthalmic emulsion
- Route
- Ophthalmic
- Packs
- 1 bottle
- Marketing authorisation holder
- Sandoz
- Manufacturer
- Sandoz
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D07AC19 Difluprednate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 January 2011
- Identifiers
- RxCUI 804544, 804547DailyMed set ID ea520a27-f569-4b31-8bad-a25ad54b2caaNDC 66758-086Application NDA022212
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 5 mL in 1 bottle | 66758-086-75 | Sandoz | 6 December 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 23 June 2008 | 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 Difluprednate 0.5 mg/mL ophthalmic emulsion.
Clinical summary
Difluprednate is a prescription medicine indicated for the treatment of inflammation and pain associated with ocular surgery, among other approved uses. It is available as ophthalmic emulsion. MedsAcross supplies Difluprednate 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 DifluprednateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Difluprednate Ophthalmic prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Durezol 0.5 mg/mL ophthalmic emulsion 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.