Quick answers
- What is Bromfenac used for?
- The FDA-approved label (Prolensa, Bausch & Lomb Incorporated, May 5, 2026) says: “PROLENSA ® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bromfenac have a boxed warning?
- No. None of the 18 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bromfenac?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bromfenac been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 7, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bromfenac?
- 13 companies list prescription products of Bromfenac in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc..
What Bromfenac is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROLENSA ® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
— FDA label: Prolensa, Bausch & Lomb Incorporated, effective May 5, 2026. Read the full label on DailyMed →
The FDA has 18 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 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 18 in the FDA NDC Directory |
| Brand names | Bromsite 0.075%, Prolensa |
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 |
|---|---|---|
| bromfenac sodium 0.7 mg/mL solution/ drops | Generic | $13.30 per mL |
| bromfenac sodium 0.7 mg/mL solution/ drops | Brand: Prolensa | $115.56 per mL |
| bromfenac sodium 0.75 mg/mL solution/ drops | Generic | $25.36 per mL |
| bromfenac sodium 0.76 mg/mL solution/ drops | Generic | $25.36 per mL |
| bromfenac sodium 0.76 mg/mL solution/ drops | Brand: Bromsite 0.075% | $49.56 per mL |
| bromfenac sodium 0.805 mg/mL solution/ drops | Generic | $13.30 per mL |
| bromfenac sodium 0.9 mg/mL solution | Generic | $15.09 per mL |
| bromfenac sodium 0.9 mg/mL solution/ drops | Generic | $15.09 per mL |
| bromfenac sodium 1.035 mg/mL solution/ drops | Generic | $15.09 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.
- Lupin Pharmaceuticals, Inc.3 products
- Alembic Pharmaceuticals Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Amneal Pharmaceuticals NY LLC1 product
- Fosun Pharma USA Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Armas Pharmaceuticals Inc.1 product
- Aurobindo Pharma Limited1 product
- Bausch & Lomb Incorporated1 product
- Apotex Corp.1 product
- Bausch & Lomb Americas Inc.1 product
- Gland Pharma Limited1 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 |
|---|---|---|---|
| NDA203168 PROLENSA | Bausch and Lomb | April 5, 2013 | 3, latest February 18, 2025 2025: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA206911 BROMSITE | Sun Pharm | April 8, 2016 | 1, latest March 9, 2023 2023: Labeling |
Generic approvals (10)
- ANDA203395Sentiss · January 22, 2014
- ANDA210560Alembic · June 21, 2019
- ANDA211029Gland · March 17, 2020
- ANDA204813Eugia Pharma · March 18, 2022
- ANDA202903Lupin · August 15, 2023
- ANDA206027Lupin · November 22, 2023
- ANDA211239Lupin · February 2, 2024
- ANDA207334Apotex · July 8, 2024
- ANDA214340Alembic · July 8, 2024
- ANDA210962Amneal · July 29, 2024
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.
-
May 7, 2025 · Class II · Ongoing · D-0447-2025
Failed Impurities/Degradation Specifications
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in — Alembic Pharmaceuticals Limited
-
March 15, 2021 · Class II · Terminated · D-0413-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS — Cardinal Health Inc.
-
January 24, 2019 · Class II · Terminated · D-0422-2019
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41 — Sun Pharmaceutical Industries, Inc.
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prolensa, Bausch & Lomb Incorporated, effective May 5, 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 →