Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops — NDC 60505-1006-2 (Billing 60505-1006-02)
This is a package of Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops from Apotex Corp., marketed since Jul 2024 and currently FDA-listed; retail pharmacies pay about $13.25 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 60505-1006-2 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60505 labeler · 1006 product · 2 package
- Package marketed since
- Jul 11, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6050510062 0
- Medicaid fills, this package
- 279 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 070835
- GCN: 34487
- GPI-14 (Medi-Span): 86805005102007
- HICL (First Databank): 013633
- AHFS class code: 52:08.20.00
- RxCUI (RxNorm): 1375917
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats inflammation and reduces eye pain after cataract surgery. It's an NSAID, the same general drug class as ibuprofen, but made as an eye drop.
- It is generally used once a day in the operated eye, starting the day before surgery. You continue on the day of surgery and through the first 14 days afterward. Follow your surgeo...
- Take out contact lenses before putting the drops in, and wait at least 10 minutes before putting them back. Other eye drops are fine to use with it, but space them at least 5 minut...
- Can I wear my contacts or use other drops?
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?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $13.250 | $39.75 / 3 ml |
| Medicaid paysCMS SDUD · 12 mo | $20.67 | $62.00 / 3 ml |
| Medicare drug plans payPart D · Q2 2026 | $30.32 | $90.97 / 3 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 60505-1006-01 60505-1006-1 | 1 BOTTLE, DROPPER in 1 CARTON / 1.6 mL in 1 BOTTLE, DROPPER | — | — | 2024-07-11 | — | Active |
| 60505-1006-02 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER | $13.25 / mL | $39.75 | 2024-07-11 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bromfenac Ophthalmic Solution, 0.07% .7 mg/mLthis 60505-1006-02 | Apotex | 1 bottle | $13.250 | AB | Availability likely | — |
| 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 | +772% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Bromfenac Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.05 mg / 1 mL
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Apotex Corp. labeler code 60505
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- Azelastine hydrochloride and Fluticasone propionate 137 ug; 50 ug Spray, Metered NDC 60505-0953-3
- Fluticasone Propionate 50 ug Spray, Metered NDC 60505-0955-1
- Ketorolac Tromethamine 5 mg/mL Solution/ Drops NDC 60505-1003-1
- Paroxetine Hydrochloride 12.5 mg Tablet, Film Coated, Extended Release NDC 60505-1316-3
- Paroxetine Hydrochloride 25 mg Tablet, Film Coated, Extended Release NDC 60505-1317-3
- Paroxetine Hydrochloride 37.5 mg Tablet, Film Coated, Extended Release NDC 60505-1318-3
- Midodrine Hydrochloride 2.5 mg Tablet NDC 60505-1320-1
- Midodrine Hydrochloride 5 mg Tablet NDC 60505-1321-1
- Pravastatin Sodium 80 mg Tablet NDC 60505-1323-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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, 0.07% 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 postsurgery. ( 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, 0.07% 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, 0.07% 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, 0.07% 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, 0.07% 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, 0.07% should not be instilled while wearing contact lenses. 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%.
5.1Sulfite Allergic Reactions Bromfenac ophthalmic solution, 0.07% 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… [Excerpted — this section continues on DailyMed.]
🤒 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 Apotex Corp. at 1-800-706-5575 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, 0.07% 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 ophthalmic solution, 0.07% 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, 0.07% 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, 0.07% 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 ophthalmic solution, 0.07% 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, 0.07%, and any potential adverse effects on the breastfed infant from bromfenac ophthalmic solution, 0.07% or from the underlying maternal conditions.
8.4Pediatric Use The safety and effectiveness of bromfenac ophthalmic solution, 0.07% have not been established in pediatric patients.
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac ophthalmic solution, 0.07% 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, 0.07% 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, 0.07% 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 ophthalmic solution, 0.07% 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, 0.07% have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness of bromfenac ophthalmic solution, 0.07% 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 plastic bottle with a white translucent LDPE dropper and gray opaque HDPE plastic cap as follows: • 1.6 mL in a 5 mL container (NDC 60505-1006-1) • 3 mL in a 5 mL container (NDC 60505-1006-2) STORAGE Store at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature].
📋 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, 0.07% 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) phenyl] acetate sesquihydrate, with an empirical formula of C 15 H 11 BrNNaO 3 • 1½ H 2 O. The chemical structure for bromfenac sodium sesquihydrate is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17.
Bromfenac Ophthalmic Solution, 0.07% is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of bromfenac ophthalmic solution, 0.07% is approximately 300 mOsmol/kg. Each mL of Bromfenac Ophthalmic Solution, 0.07% contains: Active : Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%.
Preservative : benzalkonium chloride 0.005% Inactives : boric acid, edetate disodium dihydrate, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH and water for injection. structure.jpg
💬 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 by: Manufactured for : Apotex Inc. Apotex Corp.
Toronto, Ontatio Weston, FL Canada M9L 1T9 33326 Rev. June 2026
🧬 Pharmacokinetics ▾
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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Ocular Inflammation and Pain Bromfenac 0.07% QD for the treatment of postoperative inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallel-group, and placebo (vehicle)-controlled studies. Patients undergoing cataract surgery self-administered bromfenac 0.07% or vehicle once daily, beginning 1 day prior to surgery, continuing on the morning of surgery and for 14 days after surgery. Complete clearance of ocular inflammation (0 cell and no flare) was assessed on Days 1, 3, 8, and 15 postsurgery using slit lamp biomicroscopy.
The pain score was self-reported. The primary efficacy endpoint was the proportion of subjects who had complete clearance of ocular inflammation by Day 15. In the intent-to-treat analyses from both assessments, complete clearance at Day 8 and Day 15, bromfenac 0.07% was superior to vehicle as shown in the following table.
Proportion of Subjects with Cleared Ocular Inflammation (0 cell and no flare) Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 8 27/112 (24.1%) 7/108 (6.5%) 17.6 (8.4, 26.8) At Day 15 51/112 (45.5%) 14/108 (13.0%) 32.5 (21.4, 43.8) Study 2 At Day 8 33/110 (30.0%) 14/110 (12.7%) 17.3 (6.7, 27.9) At Day 15 50/110 (45.5%) 30/110 (27.3%) 18.2 (5.7, 30.7) Proportion of Subjects Who Were Pain Free Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 1 91/112 (81.3%) 47/108 (43.5%) 37.7 (25.9, 49.6) Study 2 At Day 1 84/110 (76.4%) 61/110 (55.5%) 20.9 (8.7, 33.1)
14.1Ocular Inflammation and Pain Bromfenac 0.07% QD for the treatment of postoperative inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallel-group, and placebo (vehicle)-controlled studies. Patients undergoing cataract surgery self-administered bromfenac 0.07% or vehicle once daily, beginning 1 day prior to surgery, continuing on the morning of surgery and for 14 days after surgery. Complete clearance of ocular inflammation (0 cell and no flare) was assessed on Days 1, 3, 8, and 15 postsurgery using slit lamp biomicroscopy.
The pain score was self-reported. The primary efficacy endpoint was the proportion of subjects who had complete clearance of ocular inflammation by Day 15. In the intent-to-treat analyses from both assessments, complete clearance at Day 8 and Day 15, bromfenac 0.07% was superior to vehicle as shown in the following table.
Proportion of Subjects with Cleared Ocular Inflammation (0 cell and no flare) Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 8 27/112 (24.1%) 7/108 (6.5%) 17.6 (8.4, 26.8) At Day 15 51/112 (45.5%) 14/108 (13.0%) 32.5 (21.4, 43.8) Study 2 At Day 8 33/110 (30.0%) 14/110 (12.7%) 17.3 (6.7, 27.9) At Day 15 50/110 (45.5%) 30/110 (27.3%) 18.2 (5.7, 30.7) Proportion of Subjects Who Were Pain Free Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 1 91/112 (81.3%) 47/108 (43.5%) 37.7 (25.9, 49.6) Study 2 At Day 1 84/110 (76.4%) 61/110 (55.5%) 20.9 (8.7, 33.1)
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from RHOD assuming the human systemic concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic exposure), respectively, revealed no significant increases in tumor incidence. Mutagenesis Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests.
Impairment of Fertility Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 and 30 times the predicted human exposure, respectively).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from RHOD assuming the human systemic concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic exposure), respectively, revealed no significant increases in tumor incidence. Mutagenesis Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests.
Impairment of Fertility Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 and 30 times the predicted human exposure, respectively).
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION NDC 60505-1006-2 Bromfenac Ophthalmic Solution, 0.07% Sterile Rx only 3 mL Once Daily
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 60505-1006-2 Bromfenac Ophthalmic Solution, 0.07% Sterile Rx only 3 mL Once Daily carton.jpg