Medicine
Difluprednate 0.5 mg/mL ophthalmic emulsion
Difluprednate 0.5 mg/mL ophthalmic emulsion is a generic prescription medicine for ophthalmic use, made by 9 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
Do not freeze. Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Difluprednate
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Ophthalmic emulsion
- Route
- Ophthalmic
- Packs
- 1 bottle and 7 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCaplin SterilesIndiaCiplaIndiaDr. Reddy's LaboratoriesIndiaAmneal PharmaceuticalsLeading PharmaMylan PharmaceuticalsSandozUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68°F to 77°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
- 15 May 2013
- Identifiers
- RxCUI 804544DailyMed set ID 054ca798-454a-41cc-9d08-97bb8bef5620, 4a3b2649-ee3d-4648-91c8-912a8ba2e73c, 12803630-3196-1b3e-28e4-a598a742ef1a +7NDC 69315-329, 0378-7518, 43598-588 +7Application ANDA219441, ANDA212566, ANDA214894 +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 bottle in 1 carton / 5 mL in 1 bottle | 46708-750-05 | Alembic PharmaceuticalsIndia | 26 January 2026 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 62332-750-05 | Alembic PharmaceuticalsIndia | 26 January 2026 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 65145-161-01 | Caplin SterilesIndia | 26 December 2024 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 69097-341-35 | CiplaIndia | 9 August 2021 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 43598-588-11 | Dr. Reddy's LaboratoriesIndia | 25 December 2022 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 69238-1380-3 | Amneal Pharmaceuticals | 18 November 2021 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 69315-329-05 | Leading Pharma | 18 February 2025 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 0378-7518-35 | Mylan Pharmaceuticals | 26 September 2025 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 0781-6000-78 | Sandoz | 15 September 2021 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 0832-6054-05 | Upsher-Smith Laboratories | 21 August 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 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 Difluprednate 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.