Bromfenac .7 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 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | 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 · 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/mL 62332-0583-03 | Alembic | 1 bottle | $13.250 | AB | Availability likely | — |
| bromfenac sodium .805 mg/mL 68180-0433-02 | Lupin | 1 bottle | $13.250 | AB | Availability likely | — |
| bromfenac ophthalmic solution .7 mg/mL 75907-0093-03 | Dr. | 1 bottle | $13.250 | AB | Availability likely | — |
| bromfenac ophthalmic solution .7 mg/mL 82260-0602-03 | Bausch | 1 bottle | $13.250 | AB | Availability likely | — |
| Prolensa .7 mg/mL 24208-0602-03 | Bausch | 1 bottle | $115.554 | AB | Availability likely | — |
| Bromfenac Sodium .805 mg/mL 46708-0583-03 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Bromfenac .7 mg/mLthis 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?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60219-1526-03 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER | 2024-07-31 | 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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 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.
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%. ( 3 )
⛔ 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) Increased Bleeding Time. (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. 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.
5.6Risk 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.
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.
5.2 Slow or Delayed Healing All topical nonsteroidal anti-…
🤒 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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 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.
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 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 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 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, and any potential adverse effects on the breastfed infant from bromfenac or from the underlying maternal conditions.
8.4Pediatric Use The safety and effectiveness of bromfenac have not been established in pediatric patients.
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac 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 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 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 have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac 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 is a clear, yellow solution and supplied in white LDPE opaque bottle with a LDPE white opaque nozzle and HDPE grey cap. Each mL contains bromfenac sodium sesquihydrate 0.0805% equivalent to bromfenac free acid 0.07% . It is available as follows: 3 mL in 5 mL Container: NDC 60219-1526-3 Storage Store at 15° to 25°C (59° to 77°F).
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 a molecular formula of C 15 H 11 BrNNaO 3 •1.5 H 2 O. The chemical structure for bromfenac sodium sesquihydrate is: Bromfenac sodium is a bright orange to yellow powder. It is freely soluble in water, soluble in methanol and very slightly soluble in chloroform, dilute acid and diluted base.
The molecular weight of bromfenac sodium is 383.17 g/mol. Bromfenac ophthalmic solution is a clear, yellow solution and 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%.
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💬 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. 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.
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 by: Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2025-01