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BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops — NDC 70069-0231-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops — NDC 70069-231-01 (Billing 70069-0231-01)

by Somerset Therapeutics, LLC · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of BRIMONIDINE TARTRATE 2 mg/mL Solution/ Drops from Somerset Therapeutics, LLC, marketed since Mar 2019 and currently FDA-listed; retail pharmacies pay about $0.8530 per mL (NADAC). It is this product's only package size.

NDC 70069-0231-01
🏷️ FDA NDC (as labeled) 70069-231-01 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 →

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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 70069-231-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70069 labeler · 231 product · 01 package
Package marketed since
Mar 11, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0370069231012, 0370069232019, 0370069233016
Medicaid fills, this package
80,134 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-231-01
Product NDC 70069-231
11-digit billing NDC 70069023101
NCPDP billing unit ML — per mL (volume)
RxCUI 861200
UNII 4S9CL2DY2H
UPC 0370069231012, 0370069232019, 0370069233016
Application # ANDA208992
SPL Set ID cdb8620f-adfa-4433-b285-9c42334f8600
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-11
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BRIMONIDINE TARTRATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 86602020102010
GPI class Brimonidine Tartrate
GCN Seq No 027882
GCN 36281
HICL code 011786
Ingredient (HICL) Brimonidine Tartrate
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 52:40.04.00
AHFS class Alpha-Adrenergic Agonists (52:40)
FDB label name BRIMONIDINE 0.2% EYE DROP
FDB brand name Brimonidine Tartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027882
  • GCN: 36281
  • GPI-14 (Medi-Span): 86602020102010
  • HICL (First Databank): 011786
  • AHFS class code: 52:40.04.00
  • RxCUI (RxNorm): 861200
Why two NDCs? The FDA registers this code as 70069-231-01 — 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 → 70069-0231-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Other dermatologicals, Sympathomimetics in glaucoma therapy, Sympathomimetics used as decongestants
How it works Adrenergic alpha-Agonists
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 BRIMONIDINE 0.2% EYE DROP Ingredient Brimonidine Tartrate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Prescription eye drops lower eye pressure in glaucoma or ocular hypertension. Lumify eye drops relieve eye redness from minor irritation, and the gel tre...
  • Prescription eye drops are usually one drop three times a day, about 8 hours apart. Lumify is every 6 to 8 hours, up to 4 times a day. The rosacea gel is once a day on the face, av...
  • With the eye drops, you may notice eye itching, redness, burning, dry mouth, blurred vision, headache or sleepiness. The gel can cause redness or flushing. Most are manageable, but...
  • Get emergency help for swelling of the face, tongue or throat, or trouble breathing. Also seek help if you feel faint or your heartbeat feels very slow. If a child swallows any bri...
📖 Read our full Brimonidine guide →

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Brimonidine Tartrate (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 $0.853 $4.27 / 5 ml
Medicaid paysCMS SDUD · 12 mo $1.74 $8.69 / 5 ml
Medicare drug plans payPart D · Q2 2026 $1.05 $5.25 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.917 $0.735
▲ Up 3% over the last 24 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
70069-0231-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2019-03-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brimonidine Tartrate 2 mg/mL 70069-0233-01 Somerset 1 bottle $0.501 AT Availability likely save 41%
Brimonidine Tartrate 2 mg/mL 70069-0232-01 Somerset 1 bottle $0.579 AT Availability likely save 32%
Brimonidine Tartrate 2 mg/mL 24208-0411-05 Bausch 1 bottle $0.853 AT Availability likely —
Brimonidine Tartrate 2 mg/mL 61314-0143-05 Sandoz 5 ml $0.853 AT Availability likely —
Brimonidine Tartrate 2 mg/mLthis 70069-0231-01 Somerset 1 bottle $0.853 AT Availability likely —
Brimonidine Tartrate 2 mg/mg 71921-0185-05 Florida 5 mg $0.853 AT Availability likely —
Brimonidine Tartrate 2 mg/mg 14445-0400-05 Indoco 5 mg — AT FDA listed —
Brimonidine tartrate 2 mg/mL 42571-0419-56 Micro 1 bottle — AT 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
Mar 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.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Brimonidine 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.

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

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA208992 (ANDA)
Labeler code70069
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio184 products on file

More NDCs from Somerset Therapeutics, LLC labeler code 70069

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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE Brimonidine tartrate ophthalmic solution 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients.

This loss of effect appears with a variable time of onset in each patient and should be closely monitored.

⏱️ Dosage and Administration 80 words ▾

2 DOSAGE AND ADMINISTRATION One drop in the affected eye(s), three times daily, approximately 8 hours apart. The recommended dose is one drop of brimonidine tartrate ophthalmic solution 0.2% in the affected eye(s) three times daily, approximately 8 hours apart. Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.

If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.

💊 Dosage Forms and Strengths 17 words ▾

3 DOSAGE FORMS AND STRENGTHS Solution containing 2 mg/mL brimonidine tartrate. Solution containing 2 mg/mL brimonidine tartrate.

⛔ Contraindications 89 words ▾

4 CONTRAINDICATIONS Neonates and infants (under the age of 2 years). ( 4.1 )

4.1Neonates and Infants (under the age of 2 years) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years) [ see Use in Specific Populations ( 8.4 ) ] .

4.2Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past [ see Adverse Reactions ( 6.1 ) and ( 6.2 ) ].

⚠️ Warnings and Cautions 188 words ▾

5 WARNINGS AND PRECAUTIONS Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

5.2Severe Cardiovascular Disease Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.

5.3Contamination of Topical Ophthalmic Products After Use There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information ( 17 )] .

5.4Use with Contact Lenses The preservative in brimonidine tartrate ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling brimonidine tartrate ophthalmic solution to insert soft contact lenses.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described elsewhere in the labeling: Potentiation of Vascular Insufficiency [see Warnings and Precautions (5.1)] Severe Cardiovascular Disease [see Warnings and Precautions (<5.2)] Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions (5.3)] Neonates and Infants (under the age of 2 years) [see Contraindications (4.1)]

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10-30% of the subjects (in descending order): oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

Adverse reactions occurring in approximately 3-9% of the subjects (in descending order): corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. Adverse reactions reported < 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

6.2Postmarketing Experience The following reactions have been identified during postmarketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: Bradycardia; conjunctivitis; hypersensitivity; hypotension; iritis; keratoconjunctivitis sicca; lacrimation increased; miosis; nausea; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia.

Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence in infants receiving brimonidine tartrate ophthalmic solutions.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 )

7.1Antihypertensives/Cardiac Glycosides Because brimonidine tartrate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate ophthalmic solution is advised.

7.2CNS Depressants Although specific drug interaction studies have not been conducted with Brimonidine tartrate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

7.3Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

7.4Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Use with caution in children ≥ 2 years of age. ( 8.4 )

8.1Pregnancy Pregnancy Category B: Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with Brimonidine tartrate ophthalmic solution 0.2%, one drop in one eye, twice daily.

There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Because animal reproduction studies are not always predictive of human response, Brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

8.3Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from Brimonidine tartrate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years [see Contraindications ( 4.1 )] . During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years.

In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with Brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on Brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.

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

8.6Special Populations Brimonidine tartrate ophthalmic solution has not been studied in patients with hepatic impairment. Brimonidine tartrate ophthalmic solution has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.

🤰 Pregnancy 142 words ▾

8.1Pregnancy Pregnancy Category B: Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with Brimonidine tartrate ophthalmic solution 0.2%, one drop in one eye, twice daily.

There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Because animal reproduction studies are not always predictive of human response, Brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

🧒 Pediatric Use 143 words ▾

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years [see Contraindications ( 4.1 )] . During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years.

In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with Brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on Brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.

🧓 Geriatric Use 19 words ▾

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

🆘 Overdosage 75 words ▾

10 OVERDOSAGE Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use In Specific Populations (8.4 )] . Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

🧬 Clinical Pharmacology 138 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution 0.2% is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.

12.3Pharmacokinetics Absorption After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 hours. Distribution The protein binding of brimonidine has not been studied. Metabolism In humans, brimonidine is extensively metabolized by the liver.

Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally-administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution 0.2% is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile, in white LDPE Bottle, White LDPE Nozzle with a Purple HDPE Cap in the following sizes: 5 mL bottle in one carton – NDC 70069- 231 -01 10 mL bottle in one carton – NDC 70069- 232 -01 15 mL bottle in one carton – NDC 70069- 233 -01 Storage: Store at 15 o -25 o C (59 o -77 o F).

📋 Description 113 words ▾

11 DESCRIPTION Brimonidine tartrate ophthalmic solution 0.2%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent). The structural formula of brimonidine tartrate is: 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 In solution, brimonidine tartrate ophthalmic solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 280 -330 mOsml/kg and a pH of 5.6 -6.6.

Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.2% (2 mg/mL) with the inactive ingredients benzalkonium chloride 0.005% (0.05 mg/mL) as a preservative; citric acid; polyvinyl alcohol; sodium chloride; sodium citrate; and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Molecular structure 1

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Handling the Container Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, 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 [see Warnings and Precautions ( 5.3 )] . Always replace the cap after using.

If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle. When to Seek Physician Advice 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 multidose container .

Use with Contact Lenses Advise patients that contact lenses should be removed prior to instillation of Brimonidine tartrate ophthalmic solution and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Potential for Decreased Mental Alertness As with other similar medications, Brimonidine tartrate ophthalmic solution may cause fatigue and/or drowsiness in some patients.

Caution patients who engage in hazardous activities of the potential for a decrease in mental alertness. Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Customer Care # 1-800-417-9175 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST-BRM/P/05 1201040

🍼 Nursing Mothers 71 words ▾

8.3Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from Brimonidine tartrate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 82 words ▾

12.3Pharmacokinetics Absorption After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 hours. Distribution The protein binding of brimonidine has not been studied. Metabolism In humans, brimonidine is extensively metabolized by the liver.

Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally-administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.

🔬 Clinical Studies 150 words ▾

14 CLINICAL STUDIES Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.

In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of brimonidine tartrate ophthalmic solution was approximately 4-6 mm Hg compared with approximately 6 mm Hg for timolol. In these studies, both patient groups were dosed BID; however, due to the duration of action of brimonidine tartrate ophthalmic solution, it is recommended that brimonidine tartrate ophthalmic solution be dosed TID. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy.

Approximately 20% were discontinued due to adverse experiences.

🧪 Nonclinical Toxicology 177 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times, respectively, the plasma C max drug concentration estimated in humans treated with one drop Brimonidine tartrate ophthalmic solution 0.2% into both eyes 2 times per day . Brimonidine tartrate was not mutagenic or clastogenic in a series of in vitro and in vivo studies including the Ames bacterial reversion test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three in vivo studies in CD-1 mice: a host-mediated assay, cytogenetic study, and dominant lethal assay.

A reproduction and fertility study in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at oral doses up to 1 mg/kg, estimated as approximately 200 times the systemic exposure (AUC) following the maximum recommended human ophthalmic dose of Brimonidine tartrate ophthalmic solution 0.5%.

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mL Container label 5 mL Carton label 10 mL Container label 10 mL Carton label 15 mL Container label 15 mL Carton label 5 ml bottle label 5 mL Carton label 10 mL Container label 10 mL Carton label 15 mL Container label 15 mL Carton label

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
80.1K
Units reimbursed last 4 qtrs
527.4K
Gross reimbursed last 4 qtrs
$916.8K
Avg / prescription
$11.44
Avg / unit
$1.7384
Latest quarter Q1 2026
16.6KRx
Medicaid pays / mL
$1.7384
gross reimbursed
vs
NADAC / mL
$0.8530
acquisition cost
=
Spread
+$0.8854
+104% 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 ⓘ
39% FFS 61% MCO
Fee-for-service · 30,997 Rx Managed care · 49,137 Rx
State Medicaid map
Alaska: 765 units · 104 per 100k residents AK Maine: 800 units · 57.3 per 100k residents ME Washington: 12,840 units · 164 per 100k residents WA Idaho: 1,070 units · 54.5 per 100k residents ID Montana: 1,095 units · 96.7 per 100k residents MT North Dakota: 60 units · 7.7 per 100k residents ND Minnesota: 7,205 units · 126 per 100k residents MN Wisconsin: 11,060 units · 187 per 100k residents WI Michigan: 21,150 units · 211 per 100k residents MI New York: 47,275 units · 242 per 100k residents NY Vermont: 360 units · 55.6 per 100k residents VT New Hampshire: 970 units · 69.2 per 100k residents NH Oregon: 9,440 units · 223 per 100k residents OR Nevada: 3,990 units · 125 per 100k residents NV Wyoming: 170 units · 29.1 per 100k residents WY South Dakota: 190 units · 20.7 per 100k residents SD Iowa: 2,205 units · 68.8 per 100k residents IA Illinois: 43,970 units · 350 per 100k residents IL Indiana: 7,155 units · 104 per 100k residents IN Ohio: 20,620 units · 175 per 100k residents OH Pennsylvania: 16,770 units · 129 per 100k residents PA New Jersey: 18,860 units · 203 per 100k residents NJ Massachusetts: 11,270 units · 161 per 100k residents MA California: 77,592 units · 199 per 100k residents CA Utah: 1,695 units · 49.6 per 100k residents UT Colorado: 7,965 units · 136 per 100k residents CO Nebraska: 1,915 units · 96.8 per 100k residents NE Missouri: 8,466 units · 137 per 100k residents MO Kentucky: 8,910 units · 197 per 100k residents KY West Virginia: 2,255 units · 127 per 100k residents WV Virginia: 12,670 units · 145 per 100k residents VA Maryland: 9,515 units · 154 per 100k residents MD Connecticut: 3,240 units · 89.6 per 100k residents CT Rhode Island: 1,890 units · 173 per 100k residents RI Arizona: 16,235 units · 218 per 100k residents AZ New Mexico: 6,410 units · 303 per 100k residents NM Kansas: 1,540 units · 52.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 7,496 units · 105 per 100k residents TN North Carolina: 11,780 units · 109 per 100k residents NC South Carolina: 5,405 units · 101 per 100k residents SC Delaware: 1,410 units · 137 per 100k residents DE Oklahoma: 5,495 units · 136 per 100k residents OK Louisiana: 19,977 units · 437 per 100k residents LA Mississippi: 4,895 units · 166 per 100k residents MS Alabama: 3,771 units · 73.8 per 100k residents AL Georgia: 7,875 units · 71.4 per 100k residents GA D.C.: 3,018 units · 444 per 100k residents DC Hawaii: 1,220 units · 85.0 per 100k residents HI Texas: 11,825 units · 38.8 per 100k residents TX Florida: 19,685 units · 87.1 per 100k residents FL
Units reimbursed · per 100k residents
7.7444
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 D.C. 444 /100k
2 Louisiana 437 /100k
3 Illinois 350 /100k
4 New Mexico 303 /100k
5 New York 242 /100k
6 Oregon 223 /100k
7 Arizona 218 /100k
8 Michigan 211 /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.

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

Medicare Part D (outpatient prescription) spending for Brimonidine Tartrate — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Brimonidine Tartrate. 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
$23.5M
Claims incl. refills
685K
Beneficiaries
455K
Spend / beneficiary
$51.64
Spend / claim
$34.30
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.
← 70069-0221-06 · Somerset 70069-0232-01 · Somerset →
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.