Prescription medicine
Difluprednate Brand names: Durezol
Difluprednate (Durezol) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $9.69 per mL (Difluprednate 0.05% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the difluprednate FDA label on DailyMed (effective August 18, 2026, Sandoz Inc); the NDA 22212 record on Drugs@FDA; every difluprednate label on DailyMed.
Highlights of the record
FDA label of August 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDifluprednate ophthalmic emulsion is a corticosteroid indicated for:
The treatment of inflammation and pain associated with ocular surgery.
Forms and strengths
- 0.5 mg/ml
Emulsion.
On the market
- Earliest approval on file
- June 23, 2008 Durezol, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first August 9, 2021; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $9.69 per mL Difluprednate 0.05% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2022 0 Class I among all firms' recalls; latest August 22, 2022
- FAERS reports
- 3,802 through July 30, 2026
What is difluprednate used for?
From the label: indications and usageDifluprednate ophthalmic emulsion is a corticosteroid indicated for:
The treatment of inflammation and pain associated with ocular surgery. ( 1.1 )
The treatment of endogenous anterior uveitis. ( 1.2 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.
Source: FDA drug label (Difluprednate Ophthalmic), Sandoz Inc, effective August 18, 2026 (SPL set 0f60b857-7898-4a9e-935c-a9ddf0eb9194), via openFDA; the full label on DailyMed
Is there a generic for difluprednate (Durezol)?
The FDA approved the first generic difluprednate on August 9, 2021. 8 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists difluprednate from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2008 earliest approval on file
- 2021 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for difluprednate (Durezol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.69 per mL (Difluprednate 0.05% eye drop), down 6% from $10.32 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Difluprednate 0.05% eye drop (generic)
- Durezol 0.05% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Difluprednate 0.05% eye drop | Generic | $9.69 per mL | n/a | -6% |
| Durezol 0.05% eye drops | Brand | $42.25 per mL | n/a | -0.8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has difluprednate been recalled?
The FDA's Enforcement Report lists 4 recalls naming difluprednate since 2022: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 22, 2022 | Class II | CIPLA | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise … |
| August 2, 2022 | Class II | CIPLA | Lack of Assurance of Sterility: Complaints received of defective container closure. |
| July 14, 2022 | Class II | CIPLA | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the difluprednate label say about other medicines?
The difluprednate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorescein | warnings and precautions | The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. |
Source: FDA drug label (Difluprednate Ophthalmic), Sandoz Inc, effective August 18, 2026 (SPL set 0f60b857-7898-4a9e-935c-a9ddf0eb9194), via openFDA; the full label on DailyMed
What do FAERS reports show for difluprednate?
The FDA Adverse Event Reporting System holds 3,802 reports that list difluprednate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 635 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Difluprednate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other