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Prescription medicine · generic available

Bumetanide

Brand names: Bumex, Enbumyst

Drug class: Loop Diuretic

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

YesBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
39Companies
1983First FDA approval on file

Quick answers

What is Bumetanide used for?
The FDA-approved label (Bumex, Validus Pharmaceuticals LLC, September 8, 2025) says: “Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Bumetanide have a boxed warning?
Yes. The FDA label for Bumex has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Bumetanide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Bumetanide been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started November 6, 2013 (Class III). A recall usually concerns specific lots, not every product.
Who makes Bumetanide?
39 companies list prescription products of Bumetanide in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Sandoz Inc.

What Bumetanide is used for

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

Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. …

— FDA label: Bumex, Validus Pharmaceuticals LLC, effective September 8, 2025. Read the full label on DailyMed →

The FDA has 71 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.

This label has a boxed warning. Read it on the full label →

70 of 71 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Injection · Injection, solution · Spray
RouteOral · Intramuscular · Intravenous · Nasal
Prescription products127 in the FDA NDC Directory
Brand namesBumex, Enbumyst

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 Bumetanide, by strength and form
Strength and formGeneric or brandPharmacies pay
bumetanide 0.5 mg
tablet		 Generic $0.1331 per tablet
bumetanide 1 mg
tablet		 Generic $0.1114 per tablet
bumetanide 2 mg
tablet		 Generic $0.1855 per tablet

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

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018225
BUMEX		 Validus PharmsFebruary 28, 1983 26, latest January 17, 2024
2024: Manufacturing (CMC) · 2018: Labeling · 2017: Labeling
NDA219500
ENBUMYST		 Corstasis TherapSeptember 12, 2025 —

Generic approvals (19)

Shortage status

Shortage resolved · updated September 30, 2026 · first posted December 13, 2017

ProductBumetanide, Injection, 0.25 mg/mL, 4mL (NDC 72205-101-01)
CompanyMSN Laboratories Private Limited

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. November 6, 2013 · Class III · Terminated · D-341-2014

    Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

    Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 — Sandoz 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)197417, 197418, 197419, 205488, 205489, 205490, 282486, 1727569, 2724437, 2724443
SPL set ID of the quoted label32dfbea3-eb2b-4070-8605-57ce3e6d5a2f
FDA labels (SPL)71
FDA applicationsNDA018225, NDA219500, 19 ANDA
Active ingredients (FDA)BUMETANIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Bumex, Validus Pharmaceuticals LLC, effective September 8, 2025; 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 →

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