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Flurbiprofen Sodium
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Flurbiprofen Sodium | .3 mg/mL | 1243585 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 074447-001 | FLURBIPROFEN SODIUM | SOLUTION/DROPS | FLURBIPROFEN SODIUM | Prescription | — | RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 23 | Labeling | Approved | January 28, 2013 | Standard |
| Supplement | 13 | Labeling | Approved | December 9, 2002 | — |
| Supplement | 12 | Manufacturing (CMC) | Approved | November 27, 2001 | — |
| Supplement | 11 | Manufacturing (CMC) | Approved | April 30, 2001 | — |
| Supplement | 10 | Manufacturing (CMC) | Approved | March 7, 2001 | — |
| Supplement | 9 | Manufacturing (CMC) | Approved | June 27, 2000 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | May 18, 2000 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | April 28, 2000 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | June 7, 1999 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | November 19, 1998 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | October 22, 1998 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | August 24, 1998 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | May 28, 1998 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | April 8, 1997 | — |
| Original application | 1 | Approved | January 4, 1995 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260414). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION A total of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.
Warnings
openFDA Drug LabelingWARNINGS With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. There is the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of Flurbiprofen Sodium Ophthalmic Solution. Other adverse reactions reported with the use of Flurbiprofen Sodium Ophthalmic Solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported (see Warnings ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug LabelingDrug Interactions: Interaction of Flurbiprofen Sodium Ophthalmic Solution with other topical ophthalmic medications has not been fully investigated. 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 treated with Flurbiprofen Sodium Ophthalmic Solution.
Description
openFDA Drug LabelingDESCRIPTION Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)propionate dihydrate. Structural Formula: C 15 H 12 FNaO 2 •2H 2 O Mol. Wt. 302.27 Each mL Contains: ACTIVE: Flurbiprofen sodium 0.03%. INACTIVES: Citric Acid, Edetate Disodium, Polyvinyl Alcohol 1.4%, Potassium Chloride, Purified Water, Sodium Chloride, Sodium Citrate. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0 – 7.0). PRESERVATIVE: Thimerosal 0.005%. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Flurbiprofen sodium ophthalmic solution USP, 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 mL - NDC 69292-722-25 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT. symbol
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FLURBIPROFEN SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-3946-0 | 50090-3946 | A-S Medication Solutions | 1 BOTTLE, DROPPER in 1 CARTON (50090-3946-0) / 2.5 mL in 1 BOTTLE, DROPPER | December 10, 2018 |
| 69292-722-25 | 69292-722 | Amici Pharma, Inc. | 1 BOTTLE, DROPPER in 1 CARTON (69292-722-25) / 2.5 mL in 1 BOTTLE, DROPPER | March 31, 2018 |
| 24208-314-25 | 24208-314 | Bausch & Lomb Incorporated | 1 BOTTLE, DROPPER in 1 CARTON (24208-314-25) / 2.5 mL in 1 BOTTLE, DROPPER | January 4, 1995 |
| 63187-937-25 | 63187-937 | Proficient Rx LP | 1 BOTTLE, DROPPER in 1 CARTON (63187-937-25) / 2.5 mL in 1 BOTTLE, DROPPER | November 1, 2017 |
| 50090-3946 | 50090-3946 | A-S Medication Solutions | — | March 31, 2018 |
| 69292-722 | 69292-722 | Amici Pharma, Inc. | — | March 31, 2018 |
| 24208-314 | 24208-314 | Bausch & Lomb Incorporated | — | January 4, 1995 |
| 63187-937 | 63187-937 | Proficient Rx LP | — | January 4, 1995 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.