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Prescription medicine · generic available

Acetazolamide

Also listed by the FDA as: acetazolamide · acetazolamide sodium

Drug class: Carbonic Anhydrase Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
38Companies
1995First FDA approval on file

Quick answers

What is Acetazolamide used for?
The FDA-approved label (Acetazolamide, Strides Pharma Science Limited, August 19, 2026) says: “For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Acetazolamide have a boxed warning?
No. None of the 53 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Acetazolamide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Acetazolamide been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 24, 2024 (Class III). A recall usually concerns specific lots, not every product.
Who makes Acetazolamide?
38 companies list prescription products of Acetazolamide in the FDA NDC Directory, including Bryant Ranch Prepack, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. and A-S Medication Solutions.

What Acetazolamide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. …

— FDA label: Acetazolamide, Strides Pharma Science Limited, effective August 19, 2026. Read the full label on DailyMed →

The FDA has 53 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.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Heart failure

Related medical specialties

Cardiology

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 53 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Capsule, extended release · Injection, powder, lyophilized, for solution · Capsule · Injection, powder, for solution
RouteOral · Intravenous
Prescription products74 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.

NADAC per unit for Acetazolamide, by strength and form
Strength and formGeneric or brandPharmacies pay
acetazolamide 125 mg
tablet		 Generic $0.0964 per tablet
acetazolamide 250 mg
tablet		 Generic $0.1317 per tablet
acetazolamide 500 mg
capsule		 Generic $0.3017 per capsule
acetazolamide 500 mg
capsule, extended release		 Generic $0.3017 per capsule

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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (23)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. August 24, 2024 · Class III · Ongoing · D-0659-2024

    Discoloration

    AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01 — Rubicon Research Private Limited

  2. March 15, 2021 · Class II · Terminated · D-0490-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 — Cardinal Health 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)197303, 197304, 307702, 562524
SPL set ID of the quoted label4813b9dd-5f58-44bb-ad64-cdb331828080
FDA labels (SPL)53
FDA applications23 ANDA
Active ingredients (FDA)ACETAZOLAMIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Acetazolamide, Strides Pharma Science Limited, effective August 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers