Quick answers
- What is Metolazone used for?
- The FDA-approved label (Metolazone, Safecor Health LLC, August 12, 2026) says: “Metolazone tablets are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metolazone have a boxed warning?
- No. None of the 30 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Metolazone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Metolazone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Metolazone?
- 19 companies list prescription products of Metolazone in the FDA NDC Directory, including Bryant Ranch Prepack, Method Pharmaceuticals, LLC and Advagen Pharma Limited.
What Metolazone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Metolazone tablets are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. …
— FDA label: Metolazone, Safecor Health LLC, effective August 12, 2026. Read the full label on DailyMed →
The FDA has 30 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.
Related medical specialties
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 30 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 62 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 |
|---|---|---|
| metolazone 10 mg tablet | Generic | $0.3895 per tablet |
| metolazone 2.5 mg tablet | Generic | $0.2265 per tablet |
| metolazone 5 mg tablet | Generic | $0.2417 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.
- Bryant Ranch Prepack10 products
- Method Pharmaceuticals, LLC6 products
- Advagen Pharma Limited3 products
- Aarkish Pharmaceuticals NJ Inc.3 products
- Marlex Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Amici Pharma, Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- Alembic Pharmaceuticals Inc.3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- Sandoz Inc3 products
- Mylan Pharmaceuticals Inc.3 products
- Ingenus Pharmaceuticals, LLC3 products
- American Health Packaging2 products
- Major Pharmaceuticals2 products
- A-S Medication Solutions2 products
- Safecor Health LLC2 products
- Mylan Institutional Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA076466Sandoz · December 19, 2003
- ANDA076732Sandoz · December 19, 2003
- ANDA076698Mylan · December 23, 2003
- ANDA213251Alembic · December 2, 2020
- ANDA213827Innogenix · March 30, 2021
- ANDA214799Unichem · March 30, 2021
- ANDA215184Rubicon Research · August 20, 2021
- ANDA215616Renata · October 24, 2022
- ANDA216216Ne Rx Pharma · October 25, 2022
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) | 197978, 197979, 311671 |
|---|---|
| SPL set ID of the quoted label | efa8795e-2c89-4519-b49f-13146fb9ded1 |
| FDA labels (SPL) | 30 |
| FDA applications | 9 ANDA |
| Active ingredients (FDA) | METOLAZONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Metolazone, Safecor Health LLC, effective August 12, 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 →