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Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL Solution/ Drops, 1 bottle — NDC 62332-0508-17 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL Solution/ Drops, 1 bottle — NDC 62332-508-17 (Billing 62332-0508-17)

by Alembic Pharmaceuticals Inc. · 1 BOTTLE in 1 CARTON / 1.7 mL in 1 BOTTLE

This is a package of 1 bottle of Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL Solution/ Drops from Alembic Pharmaceuticals Inc., marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $15.63 per mL (NADAC). It is this product's only package size.

NDC 62332-0508-17
🏷️ FDA NDC (as labeled) 62332-508-17 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 62332-508-17 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62332 labeler · 508 product · 17 package
Package marketed since
Jun 21, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6233250817 4
Medicaid fills, this package
85 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · May 7, 2025 — Failed Impurities/Degradation Specifications (Alembic Pharmaceuticals Limited) · FDA recall D-0447-2025
Lots / codes: Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025 · reported Jun 4, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62332-508-17
Product NDC 62332-508
11-digit billing NDC 62332050817
NCPDP billing unit ML — per mL (volume)
RxCUI 578018
UNII 8ECV571Y37
Application # ANDA210560
SPL Set ID 225070ee-d862-4d41-84b8-5bd7a8a03fd7
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 2019-06-21
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BROMFENAC SODIUM
TE code (Orange Book) AT2 · RLD · RS

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

GPI-14 86805005102060
GPI class Bromfenac Sodium (Once-Daily)
GCN Seq No 058916
GCN 24445
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 0.09% EYE DRP
FDB brand name Bromfenac Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058916
  • GCN: 24445
  • GPI-14 (Medi-Span): 86805005102060
  • HICL (First Databank): 013633
  • AHFS class code: 52:08.20.00
  • RxCUI (RxNorm): 578018
Why two NDCs? The FDA registers this code as 62332-508-17 — 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 → 62332-0508-17. 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 BROMFENAC SODIUM 0.09% 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
  • 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $15.634 $26.58 / 1.7 ml
Medicaid paysCMS SDUD · 12 mo $41.33 $70.26 / 1.7 ml
Medicare drug plans payPart D · Q2 2026 $55.03 $93.54 / 1.7 ml
NADAC price history (per mL) — tap or hover for the price & month
Oct 2021 Oct 2022 Feb 2026 Sep 2026 $86.400 $15.184
▼ Down 75% over the last 21 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
62332-0508-17 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 1.7 mL in 1 BOTTLE 2019-06-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mLthis 62332-0508-17 Alembic 1 bottle $15.634 AT2 Availability likely —
Bromfenac .9 mg/mL 65862-0789-17 Aurobindo 1 bottle $15.634 AT2 Availability likely —
Bromfenac .9 mg/mL 68180-0436-01 Lupin 1 bottle $15.634 AT2 Availability likely —
Bromfenac .9 mg/mL 72266-0142-01 Fosun 1 bottle $15.634 AT2 Availability likely —
bromfenac 1.035 mg/mL 46708-0508-17 Alembic 1 bottle — AT2 FDA listed —
Bromfenac .9 mg/mL 68083-0313-01 Gland 1 bottle — AT2 FDA listed —
Bromfenac 1.035 mg/mL 72485-0649-71 ARMAS 1 bottle — AT2 FDA listed —
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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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.

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.

  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA210560 (ANDA)
Labeler code62332
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio492 products on file

More NDCs from Alembic Pharmaceuticals Inc. labeler code 62332

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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. BROMFENAC is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

⏱️ Dosage and Administration 128 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 post-surgery ( 2.1 ).

2.1Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period.

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

💊 Dosage Forms and Strengths 15 words ▾

3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution: bromfenac 0.09%. Topical ophthalmic solution: bromfenac 0.09%

⛔ Contraindications 3 words ▾

4 CONTRAINDICATIONS None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for cross-sensitivity ( 5.3 ) Increase bleeding of ocular tissues ( 5.4 ) Corneal effects including keratitis ( 5.5 ) Contact Lens Wear ( 5.6 )

5.1Sulfite Allergic Reactions Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

5.2Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

5.3Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.4Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

5.5Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.

Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.

Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

5.6Contact Lens Wear Bromfenac should not be administered while wearing contact lenses.

🤒 Adverse Reactions 176 words ▾

6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.

6.2Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [ see Warnings and Precautions (5) ]

👥 Use in Specific Populations 214 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects: Pregnancy Category C . Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.

Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.

8.3Nursing Mothers Caution should be exercised when bromfenac is administered to a nursing woman.

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

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

🤰 Pregnancy 147 words ▾

8.1Pregnancy Teratogenic Effects: Pregnancy Category C . Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.

Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.

🧒 Pediatric Use 18 words ▾

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

🧓 Geriatric Use 29 words ▾

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

🧬 Clinical Pharmacology 146 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 The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.09% in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

🧬 Mechanism of Action 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 47 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE screw neck bottle with a LDPE white nozzle and HDPE gray cap as follows: 1.7 mL in 5 mL container - NDC 62332-508-17 STORAGE: Store at 15° to 25°C (59° to 77°F)

📋 Description 168 words ▾

11 DESCRIPTION Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C 15 H 11 BrNNaO 3 • 3/2 H 2 O.

The structural structure for bromfenac sodium is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3.

The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains: Active : bromfenac sodium hydrate 0.1035% Preservative : benzalkonium chloride (0.05 mg/mL) Inactives : boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). Sodium hydroxide may be used to adjust pH and water for injection USP. bromfenac-struc

💬 Information for Patients 127 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Slowed or Delayed Healing Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs.

17.2Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.

17.3Concomitant Use of Contact Lenses Contact lenses should not be worn during the use of this product.

17.4Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Made in India. Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India. Or Manufactured by: Gland Pharma Limited Hyderabad-500 043,INDIA. Revised: 01/2023

🍼 Nursing Mothers 15 words ▾

8.3Nursing Mothers Caution should be exercised when bromfenac is administered to a nursing woman.

🧬 Pharmacokinetics 61 words ▾

12.3Pharmacokinetics The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.09% in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

🔬 Clinical Studies 128 words ▾

14 CLINICAL STUDIES

14.1Ocular Inflammation and Pain Following Cataract Surgery Clinical efficacy was evaluated in three randomized, double-masked, placebo controlled trials in which subjects requiring cataract surgery were assigned to Bromfenac ophthalmic solution or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15.

An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery. In 2 of the 3 studies, bromfenac ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46-47% vs. 25-29%) and also had a statistically significant higher incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs.

51-71%).

🧪 Nonclinical Toxicology 108 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the 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 (1300 and 450 times RHOD, respectively).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 105 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the 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 (1300 and 450 times RHOD, respectively).

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bromfenac Ophthalmic Solution, 0.09% - Bottle label - Gland Pharma Limited Bromfenac Ophthalmic Solution, 0.09% - Carton label - Gland Pharma Limited Bromfenac Ophthalmic Solution, 0.09% - Bottle label - Alembic Pharmaceuticals Limited Bromfenac Ophthalmic Solution, 0.09% - Carton label - Alembic Pharmaceuticals Limited bromfenac-bott bromfenac-cart bromfenac-bottle-apl bromfenac-carton-apl

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
85
Units reimbursed last 4 qtrs
168
Gross reimbursed last 4 qtrs
$6.9K
Avg / prescription
$81.69
Avg / unit
$41.2581
Latest quarter Q1 2026
29Rx
Medicaid pays / mL
$41.2581
gross reimbursed
vs
NADAC / mL
$15.6341
acquisition cost
=
Spread
+$25.6240
+164% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
15% FFS 85% MCO
Fee-for-service · 13 Rx Managed care · 72 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 29 units · 0.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 20 units · 0.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 119 units · 0.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 0.4 /100k
2 Texas 0.4 /100k
3 New York 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 0.09% — the ingredient across all brands.

Top reported reactions

Product Packaging Quantity Issue5
Visual Impairment4
Corneal Opacity3
Impaired Work Ability3
Eye Irritation2
Eye Pain2
Eye Swelling2

Age at onset

Adult1
Elderly2

Reporter sex

20 reports
Male · 44%
Female · 56%

Serious outcomes

Disabling3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 7 1
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.
← 62332-0507-05 · Alembic 62332-0510-05 · Alembic →
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.