Prescription medicine
Flurbiprofen Brand names: Lurbiro; first approved as Ocufen
Flurbiprofen (Ocufen) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $9.83 per mL (Flurbiprofen 0.03% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the flurbiprofen FDA label on DailyMed (effective July 24, 2024, Bausch & Lomb Incorporated); the NDA 19404 record on Drugs@FDA; every flurbiprofen label on DailyMed.
Highlights of the record
FDA label of July 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFlurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Forms and strengths
- 100 mg
- 0.3 mg/ml
Solution/ drops; tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 31, 1986 Ocufen, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first June 20, 1994; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $9.83 per mL Flurbiprofen 0.03% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,567 through July 30, 2026
What is flurbiprofen used for?
From the label: indications and usageFlurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Conditions named in the indications of flurbiprofen's FDA labels, with every medicine labeled for each:
From other flurbiprofen labelsRheumatoid arthritis: For relief of the signs and symptoms of rheumatoid arthritis.
Osteoarthritis: For relief of the signs and symptoms of osteoarthritis.
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Flurbiprofen Sodium), Bausch & Lomb Incorporated, effective July 24, 2024 (SPL set 11db354f-caf9-4567-811e-6c9beb1330c7), via openFDA; the full label on DailyMed
What does the patient leaflet for flurbiprofen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs" or "SNRIs" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Flurbiprofen), Genus Lifesciences, effective February 3, 2026 (SPL set 4670cf21-eb0e-4f5a-ab22-41af85733525), via openFDA; the full label on DailyMed
Is there a generic for flurbiprofen (Ocufen)?
The FDA approved the first generic flurbiprofen on June 20, 1994. 9 generic applications are approved; 2 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 flurbiprofen from 7 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 1994 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for flurbiprofen (Ocufen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.83 per mL (Flurbiprofen 0.03% eye drop), down 8% from $10.68 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.
- Flurbiprofen 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Flurbiprofen 0.03% eye drop | Generic | $9.83 per mL | n/a | -8% |
| Flurbiprofen 100 mg tablet | Generic | $3.17 per tablet | $95.20 | -3% |
| Lurbiro 100 mg tablet | Generic | $3.17 per tablet | $95.20 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the flurbiprofen label say about other medicines?
The flurbiprofen label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name flurbiprofen. 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 |
|---|---|---|
| Carbachol | drug interactions | Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients … |
Other labels that name flurbiprofen
Source: FDA drug label (Flurbiprofen Sodium), Bausch & Lomb Incorporated, effective July 24, 2024 (SPL set 11db354f-caf9-4567-811e-6c9beb1330c7), via openFDA; the full label on DailyMed
What do FAERS reports show for flurbiprofen?
The FDA Adverse Event Reporting System holds 1,567 reports that list flurbiprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 185 are coded as a death and 627 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 else is labeled for the same conditions as flurbiprofen?
25 other medicines are given the same way (oral) and in the same FDA class as flurbiprofen or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Nabumetone | Osteoarthritis, Rheumatoid arthritis | 28 labelers | $0.128 per tablet 500 mg tablet | No current entry |
Every medicine labeled for the same conditions as flurbiprofen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to flurbiprofen
- 25 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Flurbiprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other