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BRINZOLAMIDE 10 mg/mL Suspension/ Drops — NDC 00574-4012-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BRINZOLAMIDE 10 mg/mL Suspension/ Drops — NDC 0574-4012-15 (Billing 00574-4012-15)

by Padagis US LLC · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of BRINZOLAMIDE 10 mg/mL Suspension/ Drops from Padagis US LLC, marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $9.47 per mL (NADAC).

NDC 00574-4012-15
🏷️ FDA NDC (as labeled) 0574-4012-15 billing pads the labeler segment with a zero
This package
Contains15 mL in 1 bottle Cost per mL$9.47 NADAC Per package$142.11 / 15 ml Pack sizes2 compare ↓
Also priced by: Part D plans $13.69/unit — full pricing hub ↓
Product page 00574-4012-10 Also comes in: 10 mL 0574-4012-10
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 0574-4012-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0574 labeler · 4012 product · 15 package
Package marketed since
Oct 10, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0574401215 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0574-4012-15
Product NDC 0574-4012
11-digit billing NDC 00574401215
NCPDP billing unit ML — per mL (volume)
RxCUI 308805
UNII 9451Z89515
Application # ANDA211914
SPL Set ID b56a2e4b-7502-4831-a5b1-0370bdb987b1
Established class (EPC) Carbonic Anhydrase Inhibitor
Mechanism of action Carbonic Anhydrase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-10
Route OPHTHALMIC
Dosage form SUSPENSION/ DROPS
Substance BRINZOLAMIDE

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

GPI-14 86802320001820
GCN Seq No 039498
GCN 95773
HICL code 018254
Ingredient (HICL) Brinzolamide
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 Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.12.00
AHFS class Carbonic Anhydrase Inhibitors (52:40)
FDB label name BRINZOLAMIDE 1% EYE DROPS
FDB brand name Brinzolamide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 039498
  • GCN: 95773
  • GPI-14 (Medi-Span): 86802320001820
  • HICL (First Databank): 018254
  • AHFS class code: 52:40.12.00
  • RxCUI (RxNorm): 308805
Why two NDCs? The FDA registers this code as 0574-4012-15 — a 4-4-2 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 labeler segment → 00574-4012-15. 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 Carbonic Anhydrase Inhibitor class.

Pharmacologic class Carbonic Anhydrase Inhibitor
Drug family (ATC) Carbonic anhydrase inhibitors
How it works Carbonic Anhydrase 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 BRINZOLAMIDE 1% EYE DROPS Ingredient Brinzolamide
📗 Our plain-language guide HelloPharmacist
  • Brinzolamide lowers high pressure inside your eye. It is used for ocular hypertension and open-angle glaucoma. Keeping eye pressure down helps protect the optic nerve from damage.
  • It is generally one drop in the affected eye(s) 3 times a day, but follow your prescriber's directions. Shake the bottle well first. If you use other eye drops, wait at least 10 mi...
  • The most common are blurred vision and a bitter, sour, or unusual taste. Some people get eye discomfort, dryness, itching, or redness. Blurred vision can be a problem for a bit aft...
  • Stop and get help right away if you develop a severe rash, blistering or peeling skin, or other signs of a serious allergic reaction. This drop is a sulfonamide, and rarely those r...
📖 Read our full Brinzolamide Ophthalmic guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Brinzolamide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Brinzolamide (3 interactions) — ranked by severity →
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 $9.474 $142.11 / 15 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 $13.69 $205.33 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $14.301 $9.474
▼ Down 20% 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 Per unit Per pack Marketing startMarketing endStatus
00574-4012-10 0574-4012-10 Main listing 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE $8.53 / mL $85.26 2023-10-10 — Active
00574-4012-15 You're viewing this 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE $9.47 / mL $142.11 2023-10-10 — Active

Per mL, this pack runs about 11% above the cheapest pack (NDC 00574-4012-10, $8.53 vs $9.47 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 15 ml in 1 bottle.
What NDC number is used to bill for this package of BRINZOLAMIDE 10 mg/mL Suspension/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brinzolamide 10 mg/mL 00781-6014-70 Sandoz 1 bottle $8.526 AB Availability likely save 10%
Brinzolamide 10 mg/mL 24208-0464-10 Bausch 1 bottle $8.526 AB Availability likely save 10%
Brinzolamide 10 mg/mLthis 00574-4012-15 Padagis 1 bottle $9.474 — Availability likely —
Brinzolamide 10 mg/mL 68682-0464-10 Oceanside 1 bottle $14.766 AB FDA listed +56%
Azopt 10 mg/mL 66758-0085-70 Sandoz 1 bottle $35.063 AB Availability likely +270%
Brinzolamide 10 mg/mL 72162-2201-02 Bryant 1 bottle — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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

LabelerPadagis US LLC
Application holderPADAGIS US LLC
FDA applicationANDA211914 (ANDA)
Labeler code00574
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio63 products on file

More NDCs from Padagis US LLC labeler code 00574

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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. ( 1 )

⏱️ Dosage and Administration 99 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of brinzolamide ophthalmic suspension in the affected eye(s) 3 times daily. Shake well before use. Brinzolamide ophthalmic suspension may be used concomitantly with other topical ophthalmic drug products to lower IOP.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart. • Instill one drop in the affected eye(s) 3 times daily. ( 2 ) • If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart. ( 2 )

💊 Dosage Forms and Strengths 22 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic suspension containing brinzolamide 1% (10 mg/mL). Ophthalmic suspension containing brinzolamide 1% (10 mg/mL). ( 3 )

⛔ Contraindications 28 words ▾

4 CONTRAINDICATIONS Brinzolamide ophthalmic suspension is contraindicated in patients who are hypersensitive to any component of this product. Hypersensitivity to any component of this product. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Sulfonamide hypersensitivity reactions. ( 5.1 ) • Corneal edema may occur in patients with low endothelial cell counts. ( 5.2 )

5.1Sulfonamide Hypersensitivity Reactions Brinzolamide ophthalmic suspension is a sulfonamide and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of brinzolamide ophthalmic suspension. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation immediately.

5.2Corneal Endothelium Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing brinzolamide ophthalmic suspension to this group of patients.

5.3Severe Renal Impairment Brinzolamide ophthalmic suspension has not been studied in patients with severe renal impairment [creatinine clearance (CrCl) less than 30 mL/min]. Because brinzolamide ophthalmic suspension and its metabolite are excreted predominantly by the kidney, Brinzolamide ophthalmic suspension is not recommended in such patients.

5.4Acute Angle-Closure Glaucoma The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Brinzolamide ophthalmic suspension has not been studied in patients with acute angle-closure glaucoma.

5.5Risk of Contamination Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or other surfaces, since the product can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

5.6Contact Lens Wear The preservative in brinzolamide ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of brinzolamide ophthalmic suspension, but may be reinserted 15 minutes after instillation.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence 5% to 10%) are blurred vision and bitter, sour, or unusual taste. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies of brinzolamide ophthalmic suspension, the most frequently reported adverse reactions reported in 5% to 10% of patients were blurred vision and bitter, sour, or unusual taste. Adverse reactions occurring in 1% to 5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus, and rhinitis.

The following adverse reactions were reported at an incidence below 1%: allergic reactions, alopecia, chest pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing, and urticaria.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of brinzolamide containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious skin and subcutaneous tissue reactions such as Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) may occur with the use of brinzolamide due to its sulfonamide component [see Warnings and Precautions ( 5.1 )] .

🔄 Drug Interactions 156 words ▾

7 DRUG INTERACTIONS • There is a potential additive effect of the known systemic effects of carbonic anhydrase inhibition in patients receiving both oral and topical carbonic anhydrase inhibitors. ( 7.1 ) • Rare instances of acid-base alterations have occurred with high-dose salicylate therapy. ( 7.2 )

7.1Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide ophthalmic suspension. The concomitant administration of brinzolamide ophthalmic suspension and oral carbonic anhydrase inhibitors is not recommended.

7.2High-Dose Salicylate Therapy Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide. However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acid-base alterations have occurred with high-dose salicylate therapy.

Therefore, the potential for such drug interactions should be considered in patients receiving brinzolamide ophthalmic suspension.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. In reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375 times the recommended human ophthalmic dose (RHOD) based on mg/kg. In rabbits, no fetal toxicity was observed following oral administration (see Data) .

The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. Decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the RHOD based on mg/kg).

The no-observed-adverse-effect-level (NOAEL) for fetal toxicity was 6 mg/kg/day (125 times the RHOD). Decreased maternal weight gain was observed at 18 mg/kg/day. The NOAEL for maternal toxicity was 6 mg/kg/day (125 times the RHOD).

Embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. No treatment-related fetal effects were observed at any dose. The NOAEL for fetal toxicity was 6 mg/kg/day (125 times the RHOD based on mg/kg).

Maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the RHOD) and above. The NOAEL for maternal toxicity was 1 mg/kg/day (21 times the RHOD). A peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20.

Decreased pup body weight was observed at 15 mg/kg/day (313 times the RHOD based on mg/kg). The NOAEL for developmental toxicity was 5 mg/kg/day (104 times the RHOD). Following oral administration of 14 C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood.

8.2Lactation Risk Summary There are no data on the presence of brinzolamide in human milk, the effects on the breastfed infant, or the effects on milk production. Brinzolamide has been detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for brinzolamide ophthalmic suspension and any potential adverse effects on the breastfed child from brinzolamide ophthalmic suspension.

8.4Pediatric Use A 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. IOP-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0 mmHg and 2 mmHg.

Five out of 32 patients demonstrated an increase in corneal diameter of one millimeter.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. In reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375 times the recommended human ophthalmic dose (RHOD) based on mg/kg. In rabbits, no fetal toxicity was observed following oral administration (see Data) .

The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. Decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the RHOD based on mg/kg).

The no-observed-adverse-effect-level (NOAEL) for fetal toxicity was 6 mg/kg/day (125 times the RHOD). Decreased maternal weight gain was observed at 18 mg/kg/day. The NOAEL for maternal toxicity was 6 mg/kg/day (125 times the RHOD).

Embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. No treatment-related fetal effects were observed at any dose. The NOAEL for fetal toxicity was 6 mg/kg/day (125 times the RHOD based on mg/kg).

Maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the RHOD) and above. The NOAEL for maternal toxicity was 1 mg/kg/day (21 times the RHOD). A peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20.

Decreased pup body weight was observed at 15 mg/kg/day (313 times the RHOD based on mg/kg). The NOAEL for developmental toxicity was 5 mg/kg/day (104 times the RHOD). Following oral administration of 14 C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood.

🧒 Pediatric Use 85 words ▾

8.4Pediatric Use A 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. IOP-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0 mmHg and 2 mmHg.

Five out of 32 patients demonstrated an increase in corneal diameter of one millimeter.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carbonic anhydrase is an enzyme found in many tissues of the body, including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II, found primarily in red blood cells (RBCs), but also in other tissues.

Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a reduction in IOP. Brinzolamide ophthalmic suspension contains brinzolamide, an inhibitor of carbonic anhydrase II.

Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated IOP. Elevated IOP is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

12.3Pharmacokinetics Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its affinity for carbonic anhydrase II, brinzolamide distributes extensively into the RBCs and exhibits a long half-life in whole blood (approximately 111 days). In humans, the metabolite N-desethyl brinzolamide is formed, which also binds to carbonic anhydrase and accumulates in RBCs.

This metabolite binds mainly to carbonic anhydrase I in the presence of brinzolamide. In plasma, both parent brinzolamide and N-desethyl brinzolamide concentrations are low and generally below assay quantitation limits (less than 10 ng/mL). Binding to plasma proteins is approximately 60%.

Brinzolamide is eliminated predominantly in the urine as unchanged drug. N-Desethyl brinzolamide is also found in the urine along with lower concentrations of the N-desmethoxypropyl and O-desmethyl metabolites. An oral pharmacokinetic study was conducted in which healthy volunteers received 1 mg capsules of brinzolamide twice per day for up to 32 weeks.

This regimen approximates the amount of drug delivered by topical ocular administration of brinzolamide ophthalmic suspension dosed to both eyes 3 times per day and simulates systemic drug and metabolite concentrations similar to those achieved with long-term topical dosing. Red blood cell carbonic anhydrase activity was measured to assess the degree of systemic carbonic anhydrase inhibition. Brinzolamide saturation of RBC carbonic anhydrase II was achieved within 4 weeks (RBC concentrations of approximately 20 mcM).

N-Desethyl brinzolamide accumulated in RBCs to steady-state within 20 to 28 weeks reaching concentrations ranging from 6 to 30 mcM. The inhibition of carbonic anhydrase II activity at steady-state was approximately 70% to 75%, which is below the degree of inhibition expected to have a pharmacological effect on renal function or respiration in healthy subjects.

🧬 Mechanism of Action 146 words ▾

12.1Mechanism of Action Carbonic anhydrase is an enzyme found in many tissues of the body, including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II, found primarily in red blood cells (RBCs), but also in other tissues.

Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a reduction in IOP. Brinzolamide ophthalmic suspension contains brinzolamide, an inhibitor of carbonic anhydrase II.

Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated IOP. Elevated IOP is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Brinzolamide ophthalmic suspension, USP 1% is supplied in a plastic bottle with a controlled drip tip and an orange cap. 10 mL NDC 0574-4012-10 15 mL NDC 0574-4012-15 Storage and Handling Store brinzolamide ophthalmic suspension at 4°C to 30°C (39°F to 86°F). Shake well before use. After opening, brinzolamide ophthalmic suspension can be used until the expiration date on the bottle.

📋 Description 162 words ▾

11 DESCRIPTION Brinzolamide ophthalmic suspension, USP 1% contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide. Its empirical formula is C 12 H 21 N 3 O 5 S 3 , and its structural formula is: Brinzolamide has a molecular weight of 383.5 g/mol and a melting point of about 131°C.

It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol. Brinzolamide ophthalmic suspension, USP 1% is supplied as a sterile, aqueous suspension of brinzolamide which has been formulated to be readily suspended and slow settling, following shaking. It has a pH of approximately 7.5 and an osmolality of 300 mOsm/kg.

Each mL of brinzolamide ophthalmic suspension, USP 1% contains: Active ingredient: brinzolamide 10 mg; Preservative: Benzalkonium chloride 0.1 mg; Inactives: carbomer 974P, edetate disodium dihydrate, with hydrochloric acid and/or sodium hydroxide to adjust pH, mannitol, sodium chloride, tyloxapol, and water for injection. chemical

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Sulfonamide Hypersensitivity Reactions Advise patients that if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product and consult their physician immediately [see Warnings and Precautions ( 5.1 )] . Temporary Blurred Vision Vision may be temporarily blurred following dosing with brinzolamide ophthalmic suspension. Advise patients to exercise care in operating machinery or driving a motor vehicle.

Avoiding Contamination of the Product Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or other surfaces, since the product can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Intercurrent Ocular Conditions Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multi-dose container.

Concomitant Topical Ocular Therapy If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Contact Lens Wear The preservative in brinzolamide ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of brinzolamide ophthalmic suspension, but may be reinserted 15 minutes after instillation.

Manufactured for Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 08-24 3Y000 RC PH5

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its affinity for carbonic anhydrase II, brinzolamide distributes extensively into the RBCs and exhibits a long half-life in whole blood (approximately 111 days). In humans, the metabolite N-desethyl brinzolamide is formed, which also binds to carbonic anhydrase and accumulates in RBCs.

This metabolite binds mainly to carbonic anhydrase I in the presence of brinzolamide. In plasma, both parent brinzolamide and N-desethyl brinzolamide concentrations are low and generally below assay quantitation limits (less than 10 ng/mL). Binding to plasma proteins is approximately 60%.

Brinzolamide is eliminated predominantly in the urine as unchanged drug. N-Desethyl brinzolamide is also found in the urine along with lower concentrations of the N-desmethoxypropyl and O-desmethyl metabolites. An oral pharmacokinetic study was conducted in which healthy volunteers received 1 mg capsules of brinzolamide twice per day for up to 32 weeks.

This regimen approximates the amount of drug delivered by topical ocular administration of brinzolamide ophthalmic suspension dosed to both eyes 3 times per day and simulates systemic drug and metabolite concentrations similar to those achieved with long-term topical dosing. Red blood cell carbonic anhydrase activity was measured to assess the degree of systemic carbonic anhydrase inhibition. Brinzolamide saturation of RBC carbonic anhydrase II was achieved within 4 weeks (RBC concentrations of approximately 20 mcM).

N-Desethyl brinzolamide accumulated in RBCs to steady-state within 20 to 28 weeks reaching concentrations ranging from 6 to 30 mcM. The inhibition of carbonic anhydrase II activity at steady-state was approximately 70% to 75%, which is below the degree of inhibition expected to have a pharmacological effect on renal function or respiration in healthy subjects.

🔬 Clinical Studies 82 words ▾

14 CLINICAL STUDIES In two, 3-month clinical studies, brinzolamide ophthalmic suspension dosed 3 times per day in patients with elevated IOP, produced significant reductions in IOPs (4 mmHg to 5 mmHg). These IOP reductions are equivalent to the reductions observed with dorzolamide hydrochloride ophthalmic solution 2% dosed 3 times per day in the same studies. In 2 clinical studies in patients with elevated IOP, brinzolamide ophthalmic suspension was associated with less stinging and burning upon instillation than dorzolamide hydrochloride ophthalmic solution 2%.

🧪 Nonclinical Toxicology 166 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Brinzolamide caused urinary bladder tumors in female mice at oral doses of 10 mg/kg/day and in male rats at oral doses of 8 mg/kg/day in 2-year studies. Brinzolamide was not carcinogenic in male mice or female rats dosed orally for up to 2 years. The carcinogenicity appears secondary to kidney and urinary bladder toxicity.

These levels of exposure cannot be achieved with topical ophthalmic dosing in humans. Mutagenesis The following tests for mutagenic potential were negative: (1) in vivo mouse micronucleus assay; (2) in vivo sister chromatid exchange assay; and (3) Ames E. coli test. The in vitro mouse lymphoma forward mutation assay was negative in the absence of activation, but positive in the presence of microsomal activation.

Impairment of Fertility In reproduction studies of brinzolamide in rats, there were no adverse effects on the fertility or reproductive capacity of males or females at doses up to 18 mg/kg/day (375 times the RHOD based on mg/kg).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 163 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Brinzolamide caused urinary bladder tumors in female mice at oral doses of 10 mg/kg/day and in male rats at oral doses of 8 mg/kg/day in 2-year studies. Brinzolamide was not carcinogenic in male mice or female rats dosed orally for up to 2 years. The carcinogenicity appears secondary to kidney and urinary bladder toxicity.

These levels of exposure cannot be achieved with topical ophthalmic dosing in humans. Mutagenesis The following tests for mutagenic potential were negative: (1) in vivo mouse micronucleus assay; (2) in vivo sister chromatid exchange assay; and (3) Ames E. coli test. The in vitro mouse lymphoma forward mutation assay was negative in the absence of activation, but positive in the presence of microsomal activation.

Impairment of Fertility In reproduction studies of brinzolamide in rats, there were no adverse effects on the fertility or reproductive capacity of males or females at doses up to 18 mg/kg/day (375 times the RHOD based on mg/kg).

📄 Recent Major Changes 10 words ▾

Warnings and Precautions, Sulfonamide Hypersensitivity Reactions ( 5.1 ) 6/2023

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL NDC 0574-4012-10 Rx Only Brinzolamide Ophthalmic Suspension, USP 1% FOR EYE USE ONLY 10 mL Sterile eye graphic carton

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

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

Medicare Part D (outpatient prescription) spending for Brinzolamide — the program that covers self-administered drugs. 4 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 Brinzolamide. 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
$9.02M
Claims incl. refills
42K
Beneficiaries
28.6K
Spend / beneficiary
$315.93
Spend / claim
$214.90
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.
← 00574-2430-65 · PADAGIS 00574-4031-05 · Padagis →
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.