bromfenac 1.035 mg/mL Solution/ Drops, 1 bottle
🆔 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 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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the 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 0YPR65R21J
Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
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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.
8 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
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $55.03 | $93.54 / 1.7 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL 62332-0508-17 | Alembic | 1 bottle | $15.668 | AT2 | Availability likely | — |
| Bromfenac .9 mg/mL 65862-0789-17 | Aurobindo | 1 bottle | $15.668 | AT2 | Availability likely | — |
| Bromfenac .9 mg/mL 68180-0436-01 | Lupin | 1 bottle | $15.668 | AT2 | Availability likely | — |
| Bromfenac .9 mg/mL 72266-0142-01 | Fosun | 1 bottle | $15.668 | AT2 | Availability likely | — |
| bromfenac 1.035 mg/mLthis 46708-0508-17 | Alembic | 1 bottle | — | AT2 | FDA listed | — |
| Bromfenac .9 mg/mL 68083-0313-01 | Gland | 1 bottle | — | AT2 | FDA listed | — |
| Bromfenac 1.035 mg/mL 72485-0649-71 | ARMAS | 1 bottle | — | AT2 | 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?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0508-17 You're viewing this | 1 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE | 2022-11-10 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. BROMFENAC 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 extraction.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Instill one drop into the affected eye(s) 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 Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye(s) 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 & STRENGTHS Topical ophthalmic solution: bromfenac 0.09%. Topical ophthalmic solution: bromfenac 0.09%
⛔ Contraindications ▾
4 CONTRAINDICATIONS None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for cross-sensitivity ( 5.3 ) Increase bleeding of ocular tissues ( 5.4 ) Corneal effects including keratitis ( 5.5 ) Contact Lens Wear ( 5.6 )
5.1Sulfite Allergic Reactions 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) 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. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
5.4Increased Bleeding Time With some NSAIDs, 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 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 and should be closely monitored for corneal health. Post-marketing 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. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.
5.6Contact Lens Wear Bromfenac should not be administered while wearing contact lenses.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trail Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.
6.2Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [ see Warnings and Precautions (5) ]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects: Pregnancy Category C . Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.
Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: 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.
8.3Nursing Mothers Caution should be exercised when bromfenac is administered to a nursing woman.
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established.
8.5Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects: Pregnancy Category C . Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.
Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to 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 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 0.09% in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 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 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 0.09% is supplied in a white LDPE screw neck bottle with a LDPE white nozzle and HDPE gray cap as follows: 1.7 mL in 5 mL container - NDC 46708-508-17 STORAGE: Store at 15º to 25ºC (59º to 77ºF)
📋 Description ▾
11 DESCRIPTION Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). 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 • 3/2 H 2 O.
The structural structure for bromfenac sodium is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.16. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3.
The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains: Active : bromfenac sodium hydrate 0.1035% Preservative : benzalkonium chloride (0.05 mg/mL) Inactives : boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). sodium hydroxide may be used to adjust pH and water for injection USP. bromfenac-struc
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Slowed or Delayed Healing Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs.
17.2Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
17.3Concomitant Use of Contact Lenses Contact lenses should not be worn during the use of this product.
17.4Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Rx Only Manufactured by: Alembic Pharmaceuticals Limited Karkhadi – 391 450 Gujarat, India Revised: 11/2022