Quick answers
- What is Difluprednate used for?
- The FDA-approved label (Durezol, Sandoz Inc, August 18, 2026) says: “DUREZOL ® is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. • The treatment of endogenous anterior uveitis. 1.1 Ocular Surgery DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL is indicated for the treatment of endogenous anterior uveitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Difluprednate have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Difluprednate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Difluprednate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started August 22, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Difluprednate?
- 10 companies list prescription products of Difluprednate in the FDA NDC Directory, including Sandoz Inc, Cipla USA Inc. and Amneal Pharmaceuticals LLC.
What Difluprednate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DUREZOL ® is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. • The treatment of endogenous anterior uveitis. 1.1 Ocular Surgery DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL is indicated for the treatment of endogenous anterior uveitis.
— FDA label: Durezol, Sandoz Inc, effective August 18, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Emulsion |
|---|---|
| Route | Ophthalmic |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Difluprednate Ophthalmic Emulsion, Durezol |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| difluprednate 0.5 mg/mL emulsion | Generic | $9.07 per mL |
| difluprednate 0.5 mg/mL emulsion | Brand: Durezol | $42.25 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sandoz Inc2 products
- Cipla USA Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Leading Pharma, LLC1 product
- Mylan Pharmaceuticals Inc.1 product
- Upsher-Smith Laboratories, LLC1 product
- Dr. Reddy's Laboratories Inc.1 product
- Caplin Steriles Limited1 product
- Alembic Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022212 DUREZOL | Sandoz | June 23, 2008 | 10, latest August 12, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
Generic approvals (7)
- ANDA211776Cipla · August 9, 2021
- ANDA211526Amneal · November 17, 2021
- ANDA214894DR Reddys · November 16, 2022
- ANDA219441Caplin · December 13, 2024
- ANDA218191Upsher Smith Labs · February 11, 2025
- ANDA212566Mylan Labs Ltd · March 20, 2025
- ANDA213774Alembic · January 26, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 22, 2022 · Class II · Terminated · D-1499-2022
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. — CIPLA
-
August 2, 2022 · Class II · Terminated · D-1328-2022
Lack of Assurance of Sterility: Complaints received of defective container closure.
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. — CIPLA
-
July 14, 2022 · Class II · Terminated · D-1283-2022
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 I — CIPLA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 804544, 804547 |
|---|---|
| SPL set ID of the quoted label | ea520a27-f569-4b31-8bad-a25ad54b2caa |
| FDA labels (SPL) | 9 |
| FDA applications | NDA022212, 7 ANDA |
| Active ingredients (FDA) | DIFLUPREDNATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Durezol, Sandoz Inc, effective August 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →