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ALPHAGAN P brimonidine tartrate 1 mg/mL Solution/ Drops — NDC 00023-9321-15 package photo

ALPHAGAN P brimonidine tartrate 1 mg/mL Solution/ Drops

by Allergan, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (0023-9321-15) / 15 mL in 1 BOTTLE, DROPPER
NDC 00023-9321-15
🏷️ FDA NDC (as labeled) 0023-9321-15 billing pads the labeler segment with a zero
This package
Contains15 mL in 1 bottle, dropper Cost per mL$37.25 NADAC Per package$558.74 / 15 ml Pack sizes4 compare ↓
Also priced by: Medicaid pays $37.93/unit · Part D plans $39.33/unit — full pricing hub ↓
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0023-9321-15
Product NDC 0023-9321
11-digit billing NDC 00023932115
NCPDP billing unit ML — per mL (volume)
UNII 4S9CL2DY2H
UPC 0300239177109
Application # NDA021770
SPL Set ID 264c4494-c225-486f-888a-caaf36be46b3
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-01-25
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BRIMONIDINE TARTRATE
GCN Seq No 059668
GCN 25414
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 ALPHAGAN P 0.1% DROPS
FDB brand name Alphagan P
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0023-9321-15 — 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 → 00023-9321-15. 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 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.

🏭 Manufacturer & labeler

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA021770 (NDA)
Labeler code00023
First marketedJan 2006
Product typeHuman Prescription Drug
Portfolio188 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ALPHAGAN P 0.1% DROPS Ingredient Brimonidine Tartrate
📖 What it is MedlinePlus · NLM

Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) or ocular hypertension (increased pressure in the eyes). Brimonidine is in a class of drugs called alpha adrenergic agonists. Brimonidine works by decreasing the amount of fluid in the eyes.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
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  • My facial redness seems worse some days after I use the gel — is that normal?
📖 Read our full Brimonidine guide →

Supplement & herbal interactions

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

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 M4I0D6VV5M
    Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII G538EBV4VF
    Sodium chlorite is a white crystalline salt used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth to maintain product stability during storage.
  • 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $37.249 $558.74 / 15 ml
Medicaid paysCMS SDUD · 12 mo $37.93 $568.99 / 15 ml
Medicare drug plans payPart D · Q2 2026 $39.33 $589.91 / 15 ml
NADAC price history (per mL) — tap or hover for the price & month
Oct 2021 Dec 2025 Apr 2026 Aug 2026 $37.410 $33.873
▲ Up 10% over the last 12 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brimonidine Tartrate 1 mg/mL 70069-0568-01 Somerset 1 bottle $6.751 AB Availability likely save 82%
Brimonidine Tartrate 1 mg/mL 60505-0577-01 Apotex 1 bottle $10.167 AB Availability likely save 73%
Brimonidine Tartrate 1 mg/mL 62332-0749-05 Alembic 1 bottle $10.167 AB Availability likely save 73%
Brimonidine Tartrate 1 mg/mL 70069-0566-01 Somerset 1 bottle $10.167 AB Availability likely save 73%
Brimonidine tartrate 1 mg/mL 82182-0321-05 Pacific 1 bottle $10.167 AB Availability likely save 73%
Brimonidine 1 mg/mL 00781-7177-70 Sandoz 1 bottle $10.704 AB Availability likely save 71%
Brimonidine Tartrate 1 mg/mL 70069-0567-01 Somerset 1 bottle $10.704 AB Availability likely save 71%
Alphagan P 1 mg/mLthis 00023-9321-15 Allergan, 1 bottle $37.249 AB Availability likely
Brimonidine Tartrate 1 mg/mL 46708-0749-05 Alembic 1 bottle AB FDA listed
Brimonidine Tartrate 1 mg/mL 68083-0626-05 Gland 1 bottle AB FDA listed
Brimonidine Tartrate Ophthalmic Solution 1 mg/mL 70756-0677-00 Lifestar 1 bottle AB FDA listed
Brimonidine Tartrate Ophthalmic Solution 1 mg/mL 70756-0678-00 Lifestar 1 bottle AB FDA listed
Brimonidine Tartrate Ophthalmic Solution 1 mg/mL 70756-0679-00 Lifestar 1 bottle AB FDA listed
brimonidine tartrate 1 mg/mL 42571-0462-56 Micro 1 bottle AB FDA listed
Brimonidine Tartrate 1 mg/mL 00832-1435-05 Upsher-Smith 1 bottle FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

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

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

🗺️ Medicaid utilization & 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 00023-9321-15, 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 – Q4 2025 · 4 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
2.7K
Units reimbursed last 4 qtrs
42.6K
Gross reimbursed last 4 qtrs
$1.62M
Avg / prescription
$591.27
Avg / unit
$37.9327
Latest quarter Q4 2025
619Rx
Medicaid pays / mL
$37.9327
gross reimbursed
vs
NADAC / mL
$37.2492
acquisition cost
=
Spread
+$0.6835
+2% 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
93% FFS
Fee-for-service · 2,531 Rx Managed care · 202 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: 15,585 units · 79.6 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: 390 units · 3.1 per 100k residents IL Indiana: no data reported IN Ohio: 420 units · 3.6 per 100k residents OH Pennsylvania: 915 units · 7.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,305 units · 18.6 per 100k residents MA California: 23,325 units · 59.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported 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: 660 units · 6.1 per 100k residents 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.179.6
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 New York 79.6 /100k
2 California 59.9 /100k
3 Massachusetts 18.6 /100k
4 Pennsylvania 7.1 /100k
5 North Carolina 6.1 /100k
6 Ohio 3.6 /100k
7 Illinois 3.1 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle00023-9321-05 17,611 Rx · $4,554,783
1 bottle00023-9321-10 2,803 Rx · $1,118,588
1 bottle this page00023-9321-15 2,733 Rx · $1,615,933
1 bottle00023-9321-03 No Medicaid data
Drug total (last 4 qtrs): 23,147 Rx · 189,416 units · $7,289,305 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Alphagan P — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Alphagan P. 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
$8.81M
Claims incl. refills
23.7K
Beneficiaries
15.1K
Spend / beneficiary
$584.36
Spend / claim
$372.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Eye Pain558
Eye Irritation553
Ocular Hyperaemia549
Fatigue453
Vision Blurred433
Intraocular Pressure Increased389
Headache360

Reporter sex

9,138 reports

Serious outcomes

Hospitalization1,835
Disabling210
Life-threatening150
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 837 358
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00023-9321-03 1 BOTTLE, DROPPER in 1 CARTON (0023-9321-03) / 3 mL in 1 BOTTLE, DROPPER 2006-01-25 Active
00023-9321-05 1 BOTTLE, DROPPER in 1 CARTON (0023-9321-05) / 5 mL in 1 BOTTLE, DROPPER $37.35 / mL $186.76 2006-01-25 Active
00023-9321-10 1 BOTTLE, DROPPER in 1 CARTON (0023-9321-10) / 10 mL in 1 BOTTLE, DROPPER $37.30 / mL $373.00 2006-01-25 Active
00023-9321-15 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (0023-9321-15) / 15 mL in 1 BOTTLE, DROPPER $37.25 / mL $558.74 2006-01-25 Active

This pack has the lowest per-mL cost of the 3 priced pack sizes ($37.25 NADAC).

This pack accounts for about 12% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00023-9321-15?
NDC 00023-9321-15 is listed by the FDA — 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of ALPHAGAN P brimonidine tartrate 1 mg/mL Solution/ Drops?
Bill NDC 00023-9321-15 — the 11-digit billing format is 00023932115. 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.

📄 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 58 words

1 INDICATIONS AND USAGE ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN P is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

⏱️ Dosage and Administration 78 words

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop of ALPHAGAN P in the affected eye(s) three times daily, approximately 8 hours apart. ALPHAGAN P 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.

One drop in the affected eye(s) three times daily, approximately 8 hours apart. ( 2 )

💊 Dosage Forms and Strengths 32 words

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) brimonidine tartrate. Ophthalmic solution containing 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) brimonidine tartrate. ( 3 )

Contraindications 78 words

4 CONTRAINDICATIONS Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 ) Hypersensitivity Reactions. ( 4.2 )

4.1Neonates and Infants (Pediatric Patients Younger than 2 Years Old) ALPHAGAN P is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )].

4.2Hypersensitivity Reactions ALPHAGAN P is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

⚠️ Warnings and Cautions 173 words

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

5.1Potentiation of Vascular Insufficiency ALPHAGAN P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN P 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. Do not touch the tip of the dispensing container to the eye or surrounding structures.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [ see P atient C ounseling I nformation ( 17 )] .

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS 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 (Pediatric Patients Younger than 2 Years Old) [ see Contraindications ( 4.1 ) ] Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1% to 0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately 5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse reactions occurring in approximately 1% to 4% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

The following reactions were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.

6.2Postmarketing Experience The following reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solutions. 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. Bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia.

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

🔄 Drug Interactions 217 words

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 ALPHAGAN P may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with ALPHAGAN P is advised.

7.2CNS Depressants Although specific drug interaction studies have not been conducted with ALPHAGAN P, 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 ALPHAGAN P 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 ~3 min read

8 USE IN SPECIFIC POPULATIONS Use with caution in pediatric patients aged 2 years and older. ( 8.4 )

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ALPHAGAN P in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data ) .

Because animal reproduction studies are not always predictive of human response, ALPHAGAN P should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.

Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis. Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70- or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9- and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).

No treatment-related malformations were observed in rabbits. Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs. Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.

The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1100- and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). No treatment-related malformations were observed in rats. The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.

The maternal NOAEL was 1.0 mg/kg/day (250- and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.

8.2Lactation Risk Summary It is not known whether brimonidine tartrate is excreted in human milk. In animal studies, brimonidine tartrate has been shown to cross the blood-brain barrier and is excreted into breast milk after oral administration to lactating rats ( see Data ) . Because of the potential for serious adverse reactions, including central nervous system depression and apnea, from ALPHAGAN P in nursing infants, ALPHAGAN P is not recommended for use during lactation.

Data Animal Data After a single oral dose of 14 C-labeled brimonidine tartrate to lactating rats, brimonidine and metabolites were detected in milk. After male and female rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine crossed the blood-brain barrier. Radiolabel was detected in the cerebellum, cerebrum, and spinal cord.

8.4Pediatric Use ALPHAGAN P is contraindicated in pediatric patients younger than 2 years old [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. In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with ALPHAGAN P in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data ) .

Because animal reproduction studies are not always predictive of human response, ALPHAGAN P should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.

Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis. Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70- or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9- and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).

No treatment-related malformations were observed in rabbits. Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs. Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.

The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1100- and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). No treatment-related malformations were observed in rats. The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.

The maternal NOAEL was 1.0 mg/kg/day (250- and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%). After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.

🧒 Pediatric Use 128 words

8.4Pediatric Use ALPHAGAN P is contraindicated in pediatric patients younger than 2 years old [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. In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7 years old, the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% to 83% in pediatric patients aged 2 to 6 years old) and decreased alertness.

In pediatric patients aged 7 years and older (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of pediatric 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 74 words

10 OVERDOSAGE 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 ALPHAGAN P 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 141 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ALPHAGAN P 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 either a 0.1% or 0.2% solution, plasma concentrations peaked within 0.5 to 2.5 hours and declined with a systemic half-life of approximately 2 hours. Distribution Brimonidine was approximately 29% bound to plasma proteins in healthy subjects. Elimination 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 50 words

12.1Mechanism of Action ALPHAGAN P 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 94 words

16 HOW SUPPLIED/STORAGE AND HANDLING ALPHAGAN P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows: 0.1% 5 mL in 10 mL bottle NDC 0023-9321-05 10 mL in 10 mL bottle NDC 0023-9321-10 15 mL in 15 mL bottle NDC 0023-9321-15 0.15% 5 mL in 10 mL bottle NDC 0023-9177-05 10 mL in 10 mL bottle NDC 0023-9177-10 15 mL in 15 mL bottle NDC 0023-9177-15 Storage: Store at 15 o C to 25 o C (59 o F to 77 o F).

📋 Description 175 words

11 DESCRIPTION ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is: 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%).

Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE ® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.

The structural formula of brimonidine tartrate is brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent).

💬 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 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, ALPHAGAN P 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.

Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2025 AbbVie. All rights reserved.

ALPHAGAN P and its design and PURITE are trademarks of Allergan, Inc., an AbbVie company. 20091160 Abbvie logo

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