BROMFENAC SODIUM .805 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Bromfenac ophthalmic is used to treat eye swelling and redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.
Read the full MedlinePlus article ↗- Bromfenac eye drops are used specifically around the time of cataract surgery. They help reduce inflammation — the swelling and irritation inside your eye — and ease eye pain durin...
- Tilt your head back, pull down your lower eyelid gently, and place one drop into the affected eye once a day. The most important things to remember: don't let the dropper tip touch...
- How do I use the drops correctly without causing problems?
- No — take your contact lenses out before you put the drops in. The preservative in bromfenac eye drops can be absorbed by soft contact lenses, which isn't good for your eyes or you...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bromfenac Sodium — tap one for details:
Bromfenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 91MBZ8H3QO
Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII VTK01UQK3G
Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
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UNII Y27PUL9H56
Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $12.663 | $37.99 / 3 ml |
| Medicaid paysCMS SDUD · 12 mo | $22.89 | $68.67 / 3 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bromfenac Sodium .805 mg/mLthis 62332-0583-03 | Alembic | 1 bottle | $12.663 | AB | Availability likely | — |
| bromfenac sodium .805 mg/mL 68180-0433-02 | Lupin | 1 bottle | $12.663 | AB | Availability likely | — |
| bromfenac ophthalmic solution .7 mg/mL 75907-0093-03 | Dr. | 1 bottle | $12.663 | AB | Availability likely | — |
| bromfenac ophthalmic solution .7 mg/mL 82260-0602-03 | Bausch | 1 bottle | $12.663 | AB | Availability likely | — |
| Prolensa .7 mg/mL 24208-0602-03 | Bausch | 1 bottle | $115.535 | AB | Availability likely | +812% |
| Bromfenac Sodium .805 mg/mL 46708-0583-03 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Bromfenac .7 mg/mL 60219-1526-03 | Amneal | 1 bottle | — | AB | FDA listed | — |
| Bromfenac Ophthalmic Solution, 0.07% .7 mg/mL 60505-1006-01 | Apotex | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62332-0583-03 You're viewing this | 1 BOTTLE in 1 CARTON (62332-583-03) / 3 mL in 1 BOTTLE | 2024-07-08 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days post-surgery. ( 2.1 )
2.1Recommended Dosage Apply one drop to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period.
2.2Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: bromfenac 0.07% Ophthalmic solution: bromfenac 0.07%
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for Cross-Sensitivity ( 5.3 ) IncreasedBleedingTime ( 5.4 ) Keratitis and Corneal Reactions ( 5.5 )
5.1Sulfite Allergic Reactions Bromfenac ophthalmic solution contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
5.2Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
5.3Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
5.4Increased Bleeding Time With some NSAIDs, including bromfenac, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
5.5Keratitis and Corneal Reactions Use of topical NSAIDs, including bromfenac, may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
5.6Risk of Contamination Do not touch dropper tip to the eye, eyelids, or to any surface, as this may contaminate the contents. Replace the bottle cap after using.
5.7Contact Lens Wear Bromfenac ophthalmic solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of bromfenac ophthalmic solution. The preservative in bromfenac ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of bromfenac ophthalmic solution.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly reported adverse reactions following use of bromfenac ophthalmic solution following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred. These reactions were reported in 3% to 8% of patients.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on bromfenac ophthalmic solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology ( 12.3 )] . Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.
However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration.
The maternal plasma level of bromfenac following ocular administration is unknown [see Clinical Pharmacology ( 12.3 )] . Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. These doses corresponded to a C max 90- and 150- times the predicted C max at the recommended human ophthalmic dose (RHOD), respectively.
In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human C max at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human C max at the RHOD).
8.2Lactation There are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production. The systemic exposure of a breastfeeding woman to bromfenac is expected to be minimal following topical ocular administration, however, the possibility of harm to the breastfed infant cannot be ruled out. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for bromfenac ophthalmic solution, and any potential adverse effects on the breastfed infant from bromfenac ophthalmic solution or from the underlying maternal conditions.
8.4Pediatric Use The safety and effectiveness of bromfenac ophthalmic solution have not been established in pediatric patients.
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac ophthalmic solution have been observed between patients 70 years of age and older and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on bromfenac ophthalmic solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology ( 12.3 )] . Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.
However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration.
The maternal plasma level of bromfenac following ocular administration is unknown [see Clinical Pharmacology ( 12.3 )] . Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. These doses corresponded to a C max 90- and 150- times the predicted C max at the recommended human ophthalmic dose (RHOD), respectively.
In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human C max at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human C max at the RHOD).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of bromfenac ophthalmic solution have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac ophthalmic solution have been observed between patients 70 years of age and older and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation.
In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
12.3Pharmacokinetics The plasma concentration of bromfenac following ocular administration of bromfenac ophthalmic solution 0.07% in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.035 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation.
In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac ophthalmic solution 0.07% is supplied in a white Opaque LDPE bottle with White Opaque LDPE nozzle and gray HDPE cap as follows: • NDC 62332-583-03 3 mL in a 5 mL bottle Storage Store at 15ºC to 25ºC (59ºF to 77ºF). After opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle.
📋 Description ▾
11 DESCRIPTION Bromfenac ophthalmic solution 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use. Each mL of bromfenac ophthalmic solution contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium.
Bromfenac sodium is designated chemically as sodium-2-amino-3(4-bromobenzoyl)-phenylacetate sesquihydrate, with an empirical formula of C 15 H 11 BrNNaO 3 •
1.5H 2 O. The chemical structure for bromfenac sodium sesquihydrate is: Bromfenac sodium is a bright orange to yellow powder. The molecular weight of bromfenac sodium is 383.17.
Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of Bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains : Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%.
Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, and water for injection, USP. Preservative: benzalkonium chloride 0.005% bromfenac-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Risk of Contamination Advise patients to not touch dropper tip to the eye, eyelids, or to any surface, as this may contaminate the contents. Advise patients to replace bottle cap after using.
Contact Lens Wear Advise patients to remove contact lenses prior to instillation of bromfenac ophthalmic solution 0.07%. The preservative in bromfenac ophthalmic solution 0.07%, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of bromfenac ophthalmic solution 0.07%.
Use with Other Topical Ophthalmic Medications Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India Revised: 04/2025