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BROMSITE 0.075% bromfenac .76 mg/mL Solution/ Drops — NDC 49708-0754-41 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BROMSITE 0.075% bromfenac .76 mg/mL Solution/ Drops — NDC 49708-754-41 (Billing 49708-0754-41)

by Sun Pharmaceutical Industries, Inc. · 1 POUCH in 1 CARTON / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER

This is a package of BROMSITE 0.075% bromfenac .76 mg/mL Solution/ Drops from Sun Pharmaceutical Industries, Inc., marketed since May 2016 and currently FDA-listed; retail pharmacies pay about $49.55 per mL (NADAC). It is this product's only package size.

NDC 49708-0754-41
🏷️ FDA NDC (as labeled) 49708-754-41 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49708-754-41 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
49708 labeler · 754 product · 41 package
Package marketed since
May 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4970875441 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49708-754-41
Product NDC 49708-754
11-digit billing NDC 49708075441
NCPDP billing unit ML — per mL (volume)
RxCUI 1790141, 1790146
UNII 8ECV571Y37
Application # NDA206911
SPL Set ID 144a5072-341b-4591-8705-773b63044bcc
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 NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-05-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BROMFENAC SODIUM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86805005102008
GPI class BromSite
GCN Seq No 075891
GCN 41057
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 BROMSITE 0.075% EYE DROPS
FDB brand name Bromsite
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075891
  • GCN: 41057
  • GPI-14 (Medi-Span): 86805005102008
  • HICL (First Databank): 013633
  • AHFS class code: 52:08.20.00
  • RxCUI (RxNorm): 1790141
Why two NDCs? The FDA registers this code as 49708-754-41 — a 5-3-2 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 product segment → 49708-0754-41. 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.

Clinical

Label name BROMSITE 0.075% EYE DROPS 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
  • 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?
📖 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.

🧪 Full Bromfenac Sodium nutrient depletion report →
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.

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 $49.553 $247.77 / 5 ml
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 $52.26 $261.31 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
May 2021 Jan 2026 May 2026 Sep 2026 $49.770 $49.543
Flat over the last 13 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49708-0754-41 You're viewing this Main listing 1 POUCH in 1 CARTON / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER 2016-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
bromfenac 0.075% .76 mg/mL 49708-0755-41 Sun 1 pouch $24.385 AB Availability likely save 51%
Bromfenac .75 mg/mL 68180-0434-01 Lupin 1 bottle $24.385 AB Availability likely save 51%
Bromsite 0.075% .76 mg/mLthis 49708-0754-41 Sun 1 pouch $49.553 AB Availability likely —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2016
First FDA approval
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 8, 2016 AB TE-rated RLD RS ⏳ ~2.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US RE50218 — method of use (U-1834)
2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US RE50218 ↗ Method of use U-1834 Mar 5, 2029
Common questions
Is there a generic version of BROMSITE 0.075% EYE DROPS?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BROMSITE 0.075% EYE DROPS. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII W25LM17A4W
    Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

11 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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationNDA206911 (NDA)
Labeler code49708
First marketedMay 2016
Product typeHuman Prescription Drug
Portfolio891 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 49708

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.

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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE BromSite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. (1)

⏱️ Dosage and Administration 107 words ▾

2 DOSAGE AND ADMINISTRATION Instill one drop of BromSite to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. (2.1)

2.1Recommended Dosing One drop of BromSite should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery.

2.2Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. BromSite may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

💊 Dosage Forms and Strengths 16 words ▾

3 DOSAGE FORM AND STRENGTHS Topical ophthalmic solution: bromfenac 0.075%. Topical ophthalmic solution: bromfenac 0.075%. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Slow or Delayed Healing (5.1) Potential for Cross-Sensitivity (5.2) Increased Bleeding Time of Ocular Tissue (5.3) Keratitis and Corneal Effects (5.4) Contact Lens Wear (5.5)

5.1Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite (bromfenac ophthalmic solution) 0.075%, 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.

5.2Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.3Increased Bleeding Time of Ocular Tissue With some NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%, 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 BromSite be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

5.4Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.

Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%, 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.

5.5Contact Lens Wear BromSite should not be administered while wearing contact lenses. The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.

🤒 Adverse Reactions 174 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Slow or Delayed Healing [see Warnings and Precautions (5.1)] Potential for Cross-Sensitivity [see Warnings and Precautions (5.2)] Increased Bleeding Time of Ocular Tissue [see Warnings and Precautions (5.3)] Keratitis and Corneal Reactions[see Warnings and Precautions (5.4)] Contact Lens Wear [see Warnings and Precautions (5.5)] The most commonly reported adverse reactions in 1-8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 (toll free), 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 clinical practice. The most commonly reported adverse reactions in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. Clinical Considerations Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of BromSite during late pregnancy should be avoided.

Data Animal Data Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m 2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m 2 basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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; however, systemic exposure to bromfenac from ocular administration is low [see Clinical Pharmacology (12.3)]. 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 breast-fed child from bromfenac or from the underlying maternal condition.

8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established.

8.5Geriatric Use There is no evidence that the efficacy or safety profiles for BromSite differ in patients 65 years of age and older compared to younger adult patients.

🤰 Pregnancy 182 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. Clinical Considerations Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of BromSite during late pregnancy should be avoided.

Data Animal Data Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m 2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m 2 basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use There is no evidence that the efficacy or safety profiles for BromSite differ in patients 65 years of age and older compared to younger adult patients.

🧬 Clinical Pharmacology 123 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 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 Following bilateral topical ocular twice-daily dosing of Bromfenac 0.075% ophthalmic solution, the plasma concentrations of bromfenac ranged from below the limit of quantification (LOQ = 0.20 ng/mL) to 2.42 ng/mL at 30 to 60 minutes post-dose.

🧬 Mechanism of Action 82 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 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 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BromSite (bromfenac ophthalmic solution) 0.075% is supplied in white opaque low density polyethylene (LDPE) plastic bottles and translucent dropper tips, and gray high density polyethylene (HDPE) eyedropper caps. A white tamper evident overcap is provided. Each bottle is provided in a sealed foil laminated pouch.

5 mL in a 7.5 mL bottle (NDC No. 49708-754-41) STORAGE Store at 15°C to 25°C (59°F to 77°F). After opening, BromSite can be used until the expiration date on the bottle.

Discard after treatment completion.

📋 Description 152 words ▾

11 DESCRIPTION BromSite (bromfenac ophthalmic solution) 0.075% is a sterile aqueous, topical NSAID, formulated in DuraSite ® for ophthalmic use. 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 • 1½H 2 O.

The structural formula for bromfenac sodium sesquihydrate is: Bromfenac sodium is a bright orange to yellow powder. The molecular weight of bromfenac sodium sesquihydrate is 383.17. BromSite is a greenish-yellow to dark yellow viscous liquid with an osmolality of approximately 290 mOsmol/kg.

Active: Each mL contains bromfenac sodium sesquihydrate 0.87 mg, which is equivalent to bromfenac free acid 0.76 mg. Preservative: benzalkonium chloride 0.005% Inactives: boric acid, sodium borate, citric acid anhydrous, sodium citrate dihydrate, poloxamer 407, polycarbophil, sodium chloride, edetate disodium dihydrate, sodium hydroxide (to adjust pH to 8.3), and water for injection (USP). spl-bromsite-str

💬 Information for Patients 170 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, advise patients to administer BromSite at least 5 minutes after instillation of other topical medications.

Concomitant Use of Contact Lenses Advise patients not to wear contact lenses during administration of BromSite. The preservative in this product, benzalkonium chloride, may be absorbed by soft contact lenses. Sterility of Dropper Tip/Product Use Advise patients to replace the bottle cap after use and do not touch the dropper tip to any surface as this may contaminate the contents.

Advise patients to thoroughly wash hands prior to using BromSite. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 US Patent No.

8,778,999 BromSite and DuraSite are registered trademarks of Sun Pharmaceutical Industries Limited © 2022 Sun Pharmaceutical Industries, Inc. All rights reserved. Rev: MM/YYYY VISX001-642R02

🧬 Pharmacokinetics 38 words ▾

12.3Pharmacokinetics Following bilateral topical ocular twice-daily dosing of Bromfenac 0.075% ophthalmic solution, the plasma concentrations of bromfenac ranged from below the limit of quantification (LOQ = 0.20 ng/mL) to 2.42 ng/mL at 30 to 60 minutes post-dose.

🔬 Clinical Studies 209 words ▾

14 CLINICAL STUDIES

14.1Ocular Inflammation and Pain Clinical efficacy was evaluated in 2 multi-centered, randomized, double-masked, parallel group, placebo-controlled US trials in which subjects requiring cataract surgery were assigned to receive BromSite or vehicle. Patients undergoing cataract surgery self-administered BromSite or vehicle twice daily, beginning 1 day prior to surgery, continuing the day of surgery and for 14 days after surgery. Clearance of ocular inflammation was assessed on Days 1, 8, 15, and 29 using slit lamp biomicroscopy.

The primary efficacy endpoint was the proportion of subjects with anterior chamber cell (ACC) grade 0 at Day 15. The secondary efficacy endpoint was the proportion of subjects who were pain free after cataract surgery as assessed using a Visual Analog Scale. Proportion of Subjects with Cleared Ocular Inflammation, ACC Grade 0 Visit BromSite Vehicle Treatment Difference (95% CI) Study 1 Day 8 54/168 (32.1%) 7/85 (8.2%) 23.9% (14.7%, 33.1%) Day 15 96/168 (57.1%) 16/85 (18.8%) 38.3% (27.1%, 49.5%) Study 2 Day 8 40/168 (23.8%) 8/85 (9.4%) 1 4.4% (5.5%, 23.3%) Day 15 64/168 (38.1%) 19/85 (22.4%) 1 5.7% (4.2%, 27.3%) Proportion of Subjects who were Pain Free Study 1 Day 1 129/168 (76.8%) 41/85 (48.2%) 28.6% (16.2%, 40.9%) Study 2 Day 1 138/168 (82.1%) 53/85 (62.4%) 19.8% (8.0%, 31.6%)

🧪 Nonclinical Toxicology 119 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (129 times a unilateral daily dose assuming 100% absorbed, on a mg/m 2 basis) and 5 mg/kg/day (540 times a unilateral daily dose on a mg/m 2 basis), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the bacterial reverse mutation, chromosomal aberration, and micronucleus tests.

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 (195 and 65 times a unilateral daily dose, respectively, on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 116 words ▾

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (129 times a unilateral daily dose assuming 100% absorbed, on a mg/m 2 basis) and 5 mg/kg/day (540 times a unilateral daily dose on a mg/m 2 basis), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the bacterial reverse mutation, chromosomal aberration, and micronucleus tests.

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 (195 and 65 times a unilateral daily dose, respectively, on a mg/m 2 basis).

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE BromSite®[BRŏM- sahyt] (bromfenac ophthalmic solution) 0.075% Read this Instructions for Use before you start using BromSite and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Information about BromSite: • Do not let the BromSite applicator tip touch your eye, fingers, or any other surfaces. • If you are using BromSite with other eye (ophthalmic) medicines, you should wait at least 5 minutes after using the other medicine to give your BromSite dose. • You should not wear contact lenses while using BromSite. • Put the gray cap back on the BromSite after each use. Before you use BromSite for the first time: • Tear open the foil pouch using the perforated notch and remove the BromSite bottle.

Throw away the foil pouch. • Remove the white cap by turning it in the clockwise direction ( See FIGURE A ). Throw away the white cap. • Hold the bottle upright. Remove the gray cap by turning it in the counterclockwise direction ( See FIGURE B ). • Replace the gray cap on the bottle and close tightly.

Follow Steps 1 to 5 each time you use BromSite. Step 1. Wash your hands well.

Step 2. Turn the closed bottle upside down ( See FIGURE C ). Step 3.

Flick bottle firmly 1 time before each use to move the medicine into the tip of the bottle ( See FIGURE D ). Step 4. Keep the bottle upside down and remove the gray cap by turning it in the clockwise direction ( See FIGURE E ).

Step 5. Tilt your head back. Gently squeeze the bottle to place 1 drop into the affected eye ( See FIGURE F ).

Replace the gray cap on the bottle and close tightly. How do I store BromSite? • Store at 15°C to 25°C (59°F to 77°F). After opening, BromSite can be used until the expiration date on the bottle. • Throw away the BromSite bottle after your treatment is finished.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512 US Patent No. 8,778,999 BromSite and DuraSite are registered trademarks of Sun Pharmaceutical Industries Limited © 2022 Sun Pharmaceutical Industries, Inc. All rights reserved Rev.: 03/2023 VISX001650R01 spl-bromsite-fig a spl-bromsite-fig b spl-bromsite-fig c spl-bromsite-fig d spl-bromsite-fig e spl-bromsite-fig f

📄 Package Label / Principal Display Panel 36 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 49708-754-41 - 5 ML FOIL WRAPPER spl-bromsite-foil-label

PRINCIPAL DISPLAY PANEL - NDC: 49708-754-41 - 5 ML BOTTLE LABEL spl-bromsite-bottle-label

PRINCIPAL DISPLAY PANEL - NDC: 49708-754-41 - 5 ML CARTON LABEL spl-bromsite-carton-label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49708-0146-01 · Sun 49708-0755-41 · Sun →
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.