Quick answers
- What is Timolol used for?
- The FDA-approved label (Timoptic, Bausch & Lomb Incorporated, April 30, 2022) says: “TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Timolol have a boxed warning?
- No. None of the 41 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Timolol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Timolol been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started July 5, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Timolol?
- 25 companies list prescription products of Timolol in the FDA NDC Directory, including Somerset Therapeutics, LLC, Bausch & Lomb Incorporated and Bausch & Lomb Americas Inc..
What Timolol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
— FDA label: Timoptic, Bausch & Lomb Incorporated, effective April 30, 2022. Read the full label on DailyMed →
The FDA has 41 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 41 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Solution · Solution, gel forming / drops · Tablet |
|---|---|
| Route | Ophthalmic · Oral |
| Prescription products | 77 in the FDA NDC Directory |
| Brand names | Timoptic in Ocudose, Timoptic-Xe, Timoptic, Timolol Gfs, Betimol, Istalol, Timolol Maleate Ophthalmic Gel Forming Solution |
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 |
|---|---|---|
| timolol 5.12 mg/mL solution/ drops | Brand: Betimol | $31.12 per mL |
| timolol anhydrous 5 mg/mL solution/ drops | Generic | $21.33 per mL |
| timolol maleate 2.5 mg/mL solution | Generic | $0.6051–$6.29 per mL 4 packages, lowest to highest |
| timolol maleate 2.5 mg/mL solution, gel forming / drops | Generic | $6.29 per mL |
| timolol maleate 2.5 mg/mL solution/ drops | Generic | $0.6051–$6.29 per mL 13 packages, lowest to highest |
| timolol maleate 3.4 mg/mL solution/ drops | Generic | $6.43 per unit |
| timolol maleate 5 mg/mL solution | Generic | $1.24 per unit |
| timolol maleate 5 mg/mL solution | Generic | $0.7405–$7.05 per mL 11 packages, lowest to highest |
| timolol maleate 5 mg/mL solution, gel forming / drops | Generic | $7.05 per mL |
| timolol maleate 5 mg/mL solution/ drops | Generic | $0.7405–$27.35 per mL 20 packages, lowest to highest |
| timolol maleate 5 mg/mL solution/ drops | Brand: Istalol | $79.76–$80.01 per mL 2 packages, lowest to highest |
| timolol maleate 6.8 mg/mL solution | Generic | $1.24 per unit |
| timolol maleate 6.8 mg/mL solution | Brand: Timoptic in Ocudose | $10.32 per unit |
| timolol maleate 6.8 mg/mL solution/ drops | Generic | $1.24 per unit |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and October 21, 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, LLC13 products
- Bausch & Lomb Incorporated7 products
- Bausch & Lomb Americas Inc.6 products
- Rising Pharma Holdings, Inc.5 products
- A-S Medication Solutions4 products
- Lifestar Pharma LLC4 products
- Sandoz Inc4 products
- Micro Labs Limited3 products
- Caplin Steriles Limited3 products
- NorthStar RxLLC3 products
- First Nation Group, LLC2 products
- Sagent Pharmaceuticals2 products
- Alembic Pharmaceuticals Inc.2 products
- Ingenus Pharmaceuticals, LLC2 products
- Pacific Pharma, Inc.2 products
- Dr. Reddy's Laboratories Inc.2 products
- Gland Pharma Limited2 products
- Alembic Pharmaceuticals Limited2 products
- Fosun Pharma USA Inc.2 products
- Thea Pharma Inc.2 products
- Armas Pharmaceuticals Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Aurobindo Pharma Limited1 product
- Leading Pharma, LLC1 product
- Nordic Pharma, Inc.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 |
|---|---|---|---|
| NDA018086 TIMOPTIC | Bausch and Lomb Inc | August 17, 1978 | 56, latest November 17, 2021 2021: Labeling · 2016: Labeling · 2011: Labeling |
| NDA019463 TIMOPTIC IN OCUDOSE | Bausch and Lomb Inc | November 5, 1986 | 25, latest April 6, 2017 2017: Labeling · 2015: Manufacturing (CMC) · 2011: Labeling |
| NDA020330 TIMOPTIC-XE | Bausch and Lomb Inc | November 4, 1993 | 25, latest July 16, 2018 2018: Labeling · 2015: Manufacturing (CMC) · 2015: Labeling |
| NDA020439 BETIMOL | Thea Pharma | March 31, 1995 | 9, latest October 21, 2004 2004: Labeling · 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA020963 TIMOLOL MALEATE | Sandoz | October 21, 1998 | 9, latest May 28, 2024 2024: Labeling · 2014: Manufacturing (CMC) · 2007: Efficacy |
| NDA021516 ISTALOL | Bausch and Lomb | June 4, 2004 | 3, latest July 25, 2024 2024: Labeling · 2013: Labeling · 2012: Manufacturing (CMC) |
Generic approvals (22)
- ANDA072668Mylan · June 8, 1990
- ANDA074261Sandoz · April 28, 1995
- ANDA074262Sandoz · April 28, 1995
- ANDA074746Abbvie · March 25, 1997
- ANDA074747Abbvie · March 25, 1997
- ANDA077259Fdc Ltd · April 30, 2008
- ANDA078771Mankind Pharma · September 28, 2009
- ANDA207556Rising · May 2, 2019
- ANDA212942Alembic · October 22, 2020
- ANDA212592J Molner · December 13, 2021
- ANDA214645Gland · June 24, 2022
- ANDA216596Micro Labs · September 7, 2022
- ANDA216533Ingenus Pharms LLC · September 13, 2022
- ANDA215733DR Reddys · September 22, 2022
- ANDA213540Eugia Pharma · March 23, 2023
- ANDA217195Sentiss Pharma · May 8, 2023
- ANDA217343Micro Labs · May 26, 2023
- ANDA216653Somerset Theraps LLC · July 3, 2024
- ANDA217764Somerset · July 3, 2024
- ANDA218460Caplin · August 7, 2024
- ANDA210640Somerset Theraps LLC · September 16, 2024
- ANDA216654Somerset · October 10, 2024
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.
-
July 5, 2025 · Class II · Ongoing · D-0543-2025
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — FDC Limited
-
April 18, 2025 · Class II · Ongoing · D-0403-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01 — FDC Limited
-
January 23, 2025 · Class II · Ongoing · D-0214-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — FDC Limited
-
December 5, 2024 · Class II · Ongoing · D-0114-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-1 — FDC Limited
-
October 29, 2024 · Class II · Ongoing · D-0035-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — FDC Limited
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August 12, 2024 · Class II · Ongoing · D-0642-2024
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising — FDC Limited
-
July 18, 2024 · Class II · Ongoing · D-0632-2024
Defective container; yellow colored spike from cap lodged in the nozzle
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05 — FDC Limited
-
April 25, 2024 · Class II · Terminated · D-0488-2024
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Ph — FDC Limited
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March 5, 2024 · Class II · Terminated · D-0374-2024
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 — Thea Pharma, Inc.
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November 15, 2019 · Class III · Terminated · D-1367-2020
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Indust — Rising Pharmaceuticals, Inc.
-
November 15, 2019 · Class III · Terminated · D-1368-2020
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Wa — Rising Pharmaceuticals, Inc.
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
| RxCUI (RxNorm) | 198284, 198285, 198286, 208560, 313407, 313408, 861420, 861422, 1922876, 1922877 … (+10) |
|---|---|
| SPL set ID of the quoted label | 45ac65b3-19f7-4f33-aebf-cadd3daa4bf1 |
| FDA labels (SPL) | 41 |
| FDA applications | NDA018086, NDA019463, NDA020330, NDA020439, NDA020963, NDA021516, 22 ANDA |
| Active ingredients (FDA) | TIMOLOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Timoptic, Bausch & Lomb Incorporated, effective April 30, 2022; 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 →