Quick answers
- What is Dorzolamide hydrochloride used for?
- The FDA-approved label (Dorzolamide HCl, Bausch & Lomb Incorporated, June 29, 2026) says: “Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for 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 Dorzolamide hydrochloride have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dorzolamide hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dorzolamide hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dorzolamide hydrochloride?
- 14 companies list prescription products of Dorzolamide hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Advagen Pharma Ltd and Alembic Pharmaceuticals Limited.
What Dorzolamide hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
— FDA label: Dorzolamide HCl, Bausch & Lomb Incorporated, effective June 29, 2026. Read the full label on DailyMed →
The FDA has 14 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 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 15 in the FDA NDC Directory |
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 |
|---|---|---|
| dorzolamide hydrochloride 20 mg/mL solution | Generic | $0.8852 per mL |
| dorzolamide hydrochloride 20 mg/mL solution/ drops | Generic | $0.8852 per mL |
NADAC list of November 4, 2026; these prices took effect on 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.
- A-S Medication Solutions2 products
- Advagen Pharma Ltd1 product
- Alembic Pharmaceuticals Limited1 product
- Micro Labs Limited1 product
- Sagent Pharmaceuticals1 product
- Leading Pharma, LLC1 product
- Florida Pharmaceutical Products, LLC1 product
- Sandoz Inc1 product
- Alembic Pharmaceuticals Inc.1 product
- Fosun Pharma USA Inc.1 product
- Gland Pharma Limited1 product
- Somerset Therapeutics, LLC1 product
- Indoco Remedies Limited1 product
- Bausch & Lomb Incorporated1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA078395Rubicon Research · October 28, 2008
- ANDA078981Sandoz · April 13, 2009
- ANDA090143Bausch and Lomb · June 25, 2009
- ANDA202053Regcon Holdings · September 11, 2014
- ANDA205294Fdc Ltd · January 24, 2019
- ANDA212639Alembic · August 9, 2019
- ANDA204778Micro Labs · November 8, 2019
- ANDA215660Gland · January 27, 2022
- ANDA215004Somerset Theraps LLC · February 11, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 310015 |
|---|---|
| SPL set ID of the quoted label | 8417d162-65a1-4266-bca7-707af1193bf3 |
| FDA labels (SPL) | 14 |
| FDA applications | 9 ANDA |
| Active ingredients (FDA) | DORZOLAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dorzolamide HCl, Bausch & Lomb Incorporated, effective June 29, 2026; 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 →