Quick answers
- What is Brimonidine tartrate used for?
- The FDA-approved label (Alphagan P, Allergan, Inc., September 18, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Brimonidine tartrate have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Brimonidine tartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Brimonidine tartrate been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 1, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Brimonidine tartrate?
- 17 companies list prescription products of Brimonidine tartrate in the FDA NDC Directory, including Somerset Therapeutics, LLC, Lifestar Pharma LLC and Sandoz Inc.
What Brimonidine tartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Alphagan P, Allergan, Inc., effective September 18, 2025. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Gel · Solution |
|---|---|
| Route | Ophthalmic · Topical |
| Prescription products | 33 in the FDA NDC Directory |
| Brand names | Alphagan P, Mirvaso |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| brimonidine tartrate 0.5% gel | Generic | $13.84 per gram |
| brimonidine tartrate 0.5% gel | Brand: Mirvaso | $21.47 per gram |
| brimonidine tartrate 1 mg/mL solution/ drops | Generic | $6.10–$9.18 per mL 18 packages, lowest to highest |
| brimonidine tartrate 1 mg/mL solution/ drops | Brand: Alphagan P | $37.24–$37.34 per mL 3 packages, lowest to highest |
| brimonidine tartrate 1.5 mg/mL solution | Generic | $10.04–$12.29 per mL 3 packages, lowest to highest |
| brimonidine tartrate 1.5 mg/mL solution/ drops | Generic | $10.04–$12.29 per mL 9 packages, lowest to highest |
| brimonidine tartrate 1.5 mg/mL solution/ drops | Brand: Alphagan P | $39.78–$39.84 per mL 3 packages, lowest to highest |
| brimonidine tartrate 2 mg/mL solution | Generic | $0.5065–$0.8853 per mL 3 packages, lowest to highest |
| brimonidine tartrate 2 mg/mL solution/ drops | Generic | $0.5065–$0.8853 per mL 9 packages, lowest to highest |
| brimonidine tartrate 2 mg/mg solution/ drops | Generic | $0.5065–$0.8853 per mL 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Somerset Therapeutics, LLC6 products
- Lifestar Pharma LLC3 products
- Sandoz Inc3 products
- Pacific Pharma, Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Allergan, Inc.2 products
- Micro Labs Limited2 products
- Alembic Pharmaceuticals Limited2 products
- Apotex Corp.2 products
- Alembic Pharmaceuticals Inc.2 products
- Bausch & Lomb Incorporated1 product
- Indoco Remedies Limited1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- Bryant Ranch Prepack1 product
- Gland Pharma Limited1 product
- Florida Pharmaceutical Products, LLC1 product
- Galderma Laboratories, L.P.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021262 ALPHAGAN P | Abbvie | March 16, 2001 | 15, latest September 18, 2025 2025: Labeling · 2014: Manufacturing (CMC) · 2010: Labeling |
| NDA021764 QOLIANA | Sandoz | May 22, 2006 | 6, latest November 21, 2025 2025: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA021770 ALPHAGAN P | Abbvie | August 19, 2005 | 7, latest September 18, 2025 2025: Labeling · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA204708 MIRVASO | Galderma Labs LP | August 23, 2013 | 4, latest July 27, 2016 2016: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
Generic approvals (17)
- ANDA076260Bausch and Lomb Inc · May 28, 2003
- ANDA076254Sandoz · September 16, 2003
- ANDA091691Regcon Holdings · November 18, 2014
- ANDA208992Somerset Theraps LLC · March 11, 2019
- ANDA209158Padagis Israel · September 23, 2021
- ANDA078479Apotex · January 31, 2022
- ANDA078480Apotex · December 21, 2022
- ANDA215225Alembic · March 29, 2023
- ANDA216909Alembic · August 1, 2023
- ANDA217846Micro Labs · November 22, 2023
- ANDA203172Sandoz · March 4, 2024
- ANDA216772Upsher Smith Labs · June 12, 2024
- ANDA216906Somerset Theraps LLC · August 9, 2024
- ANDA217599Upsher Smith Labs · July 30, 2025
- ANDA219219Gland · March 11, 2026
- ANDA220398Mankind Pharma · April 16, 2026
- ANDA218558Micro Labs · May 7, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 1, 2023 · Class II · Completed · D-0433-2023
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, — Apotex Corp.
-
June 4, 2020 · Class III · Terminated · D-1375-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01 — SOMERSET THERAPEUTICS LLC
-
June 4, 2020 · Class III · Terminated · D-1373-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01 — SOMERSET THERAPEUTICS LLC
-
June 4, 2020 · Class III · Terminated · D-1374-2020
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01 — SOMERSET THERAPEUTICS LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Alphagan P, Allergan, Inc., effective September 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →