HomeNDC LookupIngredientsBromfenac Sodium › 60505-1006-01
Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops, 1 bottle — NDC 60505-1006-01 package photo

Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops, 1 bottle

by Apotex Corp. · 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER
NDC 60505-1006-01
🏷️ FDA NDC (as labeled) 60505-1006-1 billing pads the package segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $30.32/unit — full pricing hub ↓
Also comes in: 3 mL 60505-1006-02
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 60505-1006-1
Product NDC 60505-1006
11-digit billing NDC 60505100601
RxCUI 1375917
UNII 8ECV571Y37
Application # ANDA207334
SPL Set ID 4246c669-3c2a-2a2b-3b1c-696deb4ab519
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-11
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BROMFENAC SODIUM
GPI-14 86805005102007
GCN Seq No 070835
GCN 34487
HICL code 013633
Ingredient (HICL) Bromfenac Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.20.00
AHFS class Eent Nonsteroidal Anti-Inflam. Agents
FDB label name BROMFENAC SODIUM 0.07% EYE DRP
FDB brand name Bromfenac Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 60505-1006-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60505-1006-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Antiinflammatory agents, non-steroids
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA207334 (ANDA)
Labeler code60505
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BROMFENAC SODIUM 0.07% EYE DRP Ingredient Bromfenac Sodium
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Bromfenac Ophthalmic guide →
1
Nutrient depletion considerations

Bromfenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer 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 $30.32 $48.52 / 1.6 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bromfenac Sodium .805 mg/mL 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
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/mLthis 60505-1006-01 Apotex 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle60505-1006-02 279 Rx · $18,227
Drug total (last 4 qtrs): 279 Rx · 882 units · $18,227 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bromfenac Sodium (matched by generic name) — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bromfenac Sodium. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.3M
Claims incl. refills
43.9K
Beneficiaries
31.7K
Spend / beneficiary
$167.42
Spend / claim
$120.86
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bromfenac Ophthalmic Solution, 0.07% (this brand).

Top reported reactions

Cataract20
Nausea15
Fatigue12
Diarrhoea11
Eye Pain11
Fall10
Visual Acuity Reduced10

Reporter sex

288 reports
Male · 47%
Female · 53%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 38 9
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
60505-1006-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER 2024-07-11 Active
60505-1006-02 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER $12.66 / mL $37.99 2024-07-11 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 60505-1006-01?
NDC 60505-1006-01 contains 1 bottle — 1 bottle, dropper in 1 carton / 1.6 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Bromfenac Ophthalmic Solution, 0.07% Bromfenac Sodium .7 mg/mL Solution/ Drops?
Bill NDC 60505-1006-01 — the 11-digit billing format is 60505100601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

🧭 About this NDC listing & data coverage

Finished prescription product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 60505-1006-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 60505-1006-01, written without dashes as 60505100601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 60505-1006-01, the first segment (60505) is the labeler code FDA assigned to Apotex Corp.; the middle segment (1006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Apotex Corp.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (60505-1006-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Apotex Corp. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 60 words

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 187 words

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 16 words

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: bromfenac 0.07% Ophthalmic solution: bromfenac 0.07% ( 3 )

Contraindications 7 words

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read

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…

🤒 Adverse Reactions 217 words

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 ~2 min read

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 ~1 min read

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 19 words

8.4Pediatric Use The safety and effectiveness of bromfenac ophthalmic solution, 0.07% have not been established in pediatric patients.

🧓 Geriatric Use 30 words

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 147 words

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 83 words

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 66 words

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 180 words

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 151 words

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.