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Metolazone 5 mg Tablet, 100-count — NDC 58657-0941-01 package photo
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Metolazone 5 mg Tablet, 100-count — NDC 58657-941-01 (Billing 58657-0941-01)

by Method Pharmaceuticals, LLC · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Metolazone 5 mg Tablet from Method Pharmaceuticals, LLC, marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $0.2392 per tablet (NADAC). It is this product's only package size.

NDC 58657-0941-01
🏷️ FDA NDC (as labeled) 58657-941-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-941-01
Product NDC 58657-941
11-digit billing NDC 58657094101
NCPDP billing unit EA — each (per item)
RxCUI 197978, 197979, 311671
UNII TZ7V40X7VX
UPC 0358657741105, 0358657741013, 0358657941017, 0358657942014 +5 more
Application # ANDA213827
SPL Set ID 1a8c38aa-362e-6bcc-e063-6294a90a1e05
Established class (EPC) Thiazide-like Diuretic
Physiologic effect Increased Diuresis
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-28
Route ORAL
Dosage form TABLET
Substance METOLAZONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 37600060000310
GCN Seq No 008218
GCN 34992
HICL code 003663
Ingredient (HICL) Metolazone
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.24.00
AHFS class Thiazide-Like Diuretics (24:36)
FDB label name METOLAZONE 5 MG TABLET
FDB brand name Metolazone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008218
  • GCN: 34992
  • GPI-14 (Medi-Span): 37600060000310
  • HICL (First Databank): 003663
  • AHFS class code: 24:36.24.00
  • RxCUI (RxNorm): 197978
Why two NDCs? The FDA registers this code as 58657-941-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58657-0941-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Thiazide-like Diuretic class.

Pharmacologic class Thiazide-like Diuretic
Drug family (ATC) Sulfonamides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METOLAZONE 5 MG TABLET Ingredient Metolazone
📗 Our plain-language guide HelloPharmacist
  • It's a water pill. We use it for swelling from heart failure or kidney disease, and also for high blood pressure. Your prescriber will tell you which one applies to you.
  • Take it by mouth, usually once a day, exactly as your prescriber directs. The amount is adjusted to find the lowest one that works for you. Don't change it on your own.
  • Dizziness, tiredness, headache, stomach upset and muscle cramps are among the more common ones, and they're usually mild. Call your doctor if they are bothersome or don't settle.
  • Seek help for a severe rash or peeling skin, swelling of your face or throat, trouble breathing, fainting, or a fast or irregular heartbeat. Severe weakness or cramps can also sign...
📖 Read our full Metolazone guide →
8
Nutrient depletion considerations

Metolazone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metolazone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.239 $23.92 / 100 tablet
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.6266 $62.66 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $0.295 $0.239
▼ Down 18% over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58657-0941-01 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2026-01-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metolazone 5 mg 00185-0055-01 Sandoz 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 00378-6173-01 Mylan 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 00904-7521-61 Major 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 50742-0350-01 Ingenus 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 51079-0024-20 Mylan 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 58657-0741-01 Method 100 tablets $0.239 AB Availability likely —
Metolazone 5 mgthis 58657-0941-01 Method 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 60687-0635-01 American 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 62332-0533-31 Alembic 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 69292-0564-01 Amici 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 72888-0053-01 Advagen 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 76385-0137-01 Unichem 100 tablets $0.239 AB Availability likely —
Metolazone 5 mg 00904-7329-61 Major 100 tablets $0.264 AB Discontinued +11%
Metolazone 5 mg 10135-0766-01 Marlex 100 tablets — AB FDA listed —
Metolazone 5 mg 42571-0417-01 Micro 100 tablets — AB Discontinued —
Metolazone 5 mg 43353-0931-09 Aphena 9000 tablets — AB FDA listed —
Metolazone 5 mg 46708-0533-31 Alembic 100 tablets — AB FDA listed —
Metolazone 5 mg 48433-0069-20 Safecor 100 tablets — AB FDA listed —
Metolazone 5 mg 51407-0432-01 Golden 100 tablets — AB FDA listed —
Metolazone 5 mg 63629-7875-01 Bryant 30 tablets — AB FDA listed —
Metolazone 5 mg 63629-8733-01 Bryant 100 tablets — AB FDA listed —
Metolazone 5 mg 71335-1944-01 Bryant 30 tablets — AB FDA listed —
Metolazone 5 mg 71335-2850-01 Bryant 100 tablets — AB FDA listed —
Metolazone 5 mg 72162-1050-01 Bryant 100 tablets — AB FDA listed —
Metolazone 5 mg 72162-2390-01 Bryant 100 tablets — AB FDA listed —
Metolazone 5 mg 81005-0125-01 Aarkish 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink / orange / yellow
ShapeRound
ImprintI123
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMethod Pharmaceuticals, LLC
Application holderINNOGENIX LLC
FDA applicationANDA213827 (ANDA)
Labeler code58657
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio78 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Metolazone tablets, USP, 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, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension.

A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. Usage In Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard.

Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS ).

Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief.

In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Effective dosage of metolazone tablets, USP, should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with metolazone tablets, USP, should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.

Usual Single Daily Dosage Schedules Suitable initial dosages will usually fall in the ranges given. Edema of cardiac failure: Metolazone tablets, USP, 5 to 20 mg once daily. Edema of renal disease: Metolazone tablets, USP, 5 to 20 mg once daily.

Mild to moderate essential hypertension: Metolazone tablets, USP, 2½ to 5 mg once daily. New patients – MYKROX Tablets (metolazone tablets, USP) (see MYKROX package circular). If considered desirable to switch patients currently on metolazone tablets, USP, to MYKROX, the dose should be determined by titration starting at one tablet (½ mg) once daily and increasing to two tablets (1 mg) once daily if needed.

Treatment Of Edematous States The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible.

The daily dose depends on the severity of the patient's condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with metolazone tablets, USP, more careful dosage adjustment may be necessary.

For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period. Treatment Of Hypertension The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.

⚠️ Warnings ~1 min read ▾

WARNINGS Rapid Onset Hyponatremia And/Or Hypokalemia Rarely, the rapid onset of severe hyponatremia and/or hypokalemia has been reported following initial doses of thiazide and non-thiazide diuretics. When symptoms consistent with severe electrolyte imbalance appear rapidly, drug should be discontinued and supportive measures should be initiated immediately. Parenteral electrolytes may be required.

Appropriateness of therapy with this class of drugs should be carefully reevaluated. Hypokalemia Hypokalemia may occur with consequent weakness, cramps, and cardiac dysrhythmias. Serum potassium should be determined at regular and appropriate intervals, and dose reduction, potassium supplementation or addition of a potassium-sparing diuretic instituted whenever indicated.

Hypokalemia is a particular hazard in patients who are digitalized or who have or have had a ventricular arrhythmia; dangerous or fatal arrhythmias may be precipitated. Hypokalemia is dose related. Concomitant Therapy Lithium In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity.

Read prescribing information for lithium preparations before use of such concomitant therapy. Furosemide Unusually large or prolonged losses of fluids and electrolytes may result when metolazone tablets, USP, are administered concomitantly to patients receiving furosemide (see PRECAUTIONS , Drug Interactions ). Other Antihypertensive Drugs When metolazone tablets, USP, are used with other antihypertensive drugs, particular care must be taken to avoid excessive reduction of blood pressure, especially during initial therapy.

Cross-Allergy Cross-allergy may occur when metolazone tablets, USP, are given to patients known to be allergic to sulfonamide-derived drugs, thiazides, or quinethazone. Sensitivity Reactions Sensitivity reactions (e.g., angioedema, bronchospasm) may occur with or without a history of allergy or bronchial asthma and may occur with the first dose of metolazone tablets, USP.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Metolazone tablets, USP, are usually well tolerated, and most reported adverse reactions have been mild and transient. Many of metolazone tablets, USP, related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or its renal/metabolic actions. The following adverse reactions have been reported.

Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems. Cardiovascular Chest pain/discomfort, orthostatic hypotension, excessive volume depletion, hemoconcentration, venous thrombosis, palpitations.

Central And Peripheral Nervous System Syncope, neuropathy, vertigo, paresthesias, psychotic depression, impotence, dizziness/lightheadedness, drowsiness, fatigue, weakness, restlessness (sometimes resulting in insomnia), headache. Dermatologic/Hypersensitivity Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis (photosensitivity), urticaria, pruritus, skin rashes. Gastrointestinal Hepatitis, intrahepatic cholestatic jaundice, pancreatitis, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating, abdominal pain.

Hematologic Aplastic/hypoplastic anemia, agranulocytosis, leukopenia, thrombocytopenia. Metabolic Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia, glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia, hypomagnesemia, hypercalcemia. Musculoskeletal Joint pain, acute gouty attacks, muscle cramps or spasm.

Other Transient blurred vision, chills, dry mouth. In addition, adverse reactions reported with similar antihypertensive-diuretics, but which have not been reported to date for metolazone tablets, USP, include: bitter taste, sialadenitis, xanthopsia, respiratory distress (including pneumonitis), and anaphylactic reactions. These reactions should be considered as possible occurrences with clinical usage of metolazone tablets, USP.

Whenever adverse reactions are moderate or severe, metolazone tablets, USP, dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Innogenix, LLC. at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 160 words ▾

OVERDOSAGE Intentional overdosage has been reported rarely with metolazone and similar diuretic drugs. Signs And Symptoms Orthostatic hypotension, dizziness, drowsiness, syncope, electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion may occur. In some instances depressed respiration may be observed.

At high doses, lethargy of varying degree may progress to coma within a few hours. The mechanism of CNS depression with thiazide overdosage is unknown. Also, GI irritation and hypermotility may occur.

Temporary elevation of BUN has been reported, especially in patients with impairment of renal function. Serum electrolyte changes and cardiovascular and renal function should be closely monitored. Treatment There is no specific antidote available but immediate evacuation of stomach contents is advised.

Dialysis is not likely to be effective. Care should be taken when evacuating the gastric contents to prevent aspiration, especially in the stuporous or comatose patient. Supportive measures should be initiated as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Metolazone is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. The actions of metolazone result from interference with the renal tubular mechanism of electrolyte reabsorption. Metolazone acts primarily to inhibit sodium reabsorption at the cortical diluting site and to a lesser extent in the proximal convoluted tubule.

Sodium and chloride ions are excreted in approximately equivalent amounts. The increased delivery of sodium to the distal tubular exchange site results in increased potassium excretion. Metolazone does not inhibit carbonic anhydrase.

A proximal action of metolazone has been shown in humans by increased excretion of phosphate and magnesium ions and by a markedly increased fractional excretion of sodium in patients with severely compromised glomerular filtration. This action has been demonstrated in animals by micropuncture studies. When metolazone tablets, USP, are given, diuresis and saluresis usually begin within one hour and may persist for 24 hours or more.

For most patients, the duration of effect can be varied by adjusting the daily dose. High doses may prolong the effect. A single daily dose is recommended.

When a desired therapeutic effect has been obtained, it may be possible to reduce dosage to a lower maintenance level. The diuretic potency of metolazone tablets, USP, at maximum therapeutic dosage is approximately equal to thiazide diuretics. However, unlike thiazides, metolazone tablets, USP, may produce diuresis in patients with glomerular filtration rates below 20 mL/min.

Metolazone tablets, USP, and furosemide administered concurrently have produced marked diuresis in some patients where edema or ascites was refractory to treatment with maximum recommended doses of these or other diuretics administered alone. The mechanism of this interaction is unknown (see WARNINGS and PRECAUTIONS , Drug Interactions ). Maximum blood levels of metolazone are found approximately eight hours after dosing.

A small fraction of metolazone is metabolized. Most of the drug is excreted in the unconverted form in the urine.

📦 How Supplied / Storage and Handling 210 words ▾

HOW SUPPLIED Metolazone Tablets, USP for oral administration are available as: 2.5 mg: Peach, round, biconvex tablets debossed with “I” on one side and “121” on the other side and supplied as: NDC 58657-740-01 bottles of 100 NDC 58657-740-10 bottles of 1000 NDC 58657-940-01 Carton of 100 tablets (10 tablets per blister pack x 10) 5 mg: Pink, round, biconvex tablets debossed with “I” on one side and “122” on the other side and supplied as: NDC 58657-741-01 bottles of 100 NDC 58657-741-10 bottles of 1000 NDC 58657-941-01 Carton of 100 tablets (10 tablets per blister pack x 10) 10 mg: Orange, round, biconvex tablets debossed with “I” on one side and “123” on the other side and supplied as: NDC 58657-742-01 bottles of 100 NDC 58657-742-10 bottles of 1000 NDC 58657-942-01 Carton of 100 tablets (10 tablets per blister pack x 10) STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature] Protect from light.

Keep out of the reach of children. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Distributed by: Method Pharmaceutials, LLC Southlake, TX 76092 All brandnames are trademarks of their respective owners.

Rev. 01/2026

📋 Description 100 words ▾

DESCRIPTION Metolazone tablets, USP, for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16 H 16 ClN 3 O 3 S, the chemical name 7-chloro-1,2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4- oxo-6-quinazolinesulfonamide and a molecular weight of 365.83. The structural formula is: Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents.

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and dye: 2 ½ mg o. 6; 5 mg - D&C Red #30; 10 mg - FD&C Yellow No.6. Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS DO NOT INTERCHANGE DO NOT INTERCHANGE METOLAZONE TABLETS, USP, ZAROXOLYN TABLETS, AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE THEIR SLOW AND INCOMPLETE BIOAVAILABILITY AND ARE NOT THERAPEUTICALLY EQUIVALENT AT THE SAME DOSES TO MYKROX TABLETS, A MORE RAPIDLY AVAILABLE AND COMPLETELY BIOAVAILABLE METOLAZONE PRODUCT. FORMULATIONS BIOEQUIVALENT TO ZAROXOLYN AND FORMULATIONS BIOEQUIVALENT TO MYKROX SHOULD NOT BE INTERCHANGED FOR ONE ANOTHER. General Fluid And Electrolytes All patients receiving therapy with metolazone tablets, USP, should have serum electrolyte measurements done at appropriate intervals and be observed for clinical signs of fluid and/or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia.

In patients with severe edema accompanying cardiac failure or renal disease, a low-salt syndrome may be produced, especially with hot weather and a low-salt diet. Serum and urine electrolyte determinations are particularly important when the patient has protracted vomiting, severe diarrhea, or is receiving parenteral fluids. Warning signs of imbalance are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hyponatremia may occur at any time during long term therapy and, on rare occasions, may be life threatening. The risk of hypokalemia is increased when larger doses are used, when diuresis is rapid, when severe liver disease is present, when corticosteroids are given concomitantly, when oral intake is inadequate or when excess potassium is being lost extrarenally, such as with vomiting or diarrhea. Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Glucose Tolerance Metolazone may raise blood glucose concentrations possibly causing hyperglycemia and glycosuria in patients with diabetes or latent diabetes. Hyperuricemia Metolazone tablets, USP, regularly cause an increase in serum uric acid and can occasionally precipitate gouty attacks even in patients without a prior history of them. Azotemia Azotemia, presumably prerenal azotemia, may be precipitated during the administration of metolazone tablets, USP.

If azotemia and oliguria worsen during treatment of patients with severe renal disease, metolazone tablets, USP, should be discontinued. Renal Impairment Use caution when administering metolazone tablets, USP, to patients with severely impaired renal function. As most of the drug is excreted by the renal route, accumulation may occur.

Orthostatic Hypotension Orthostatic hypotension may occur; this may be potentiated by alcohol, barbiturates, narcotics, or concurrent therapy with other antihypertensive drugs. Hypercalcemia Hypercalcemia may infrequently occur with metolazone, especially in patients taking high doses of vitamin D or with high bone turnover states, and may signify hidden hyperparathyroidism. Metolazone should be discontinued before tests for parathyroid function are performed.

Systemic Lupus Erythematosus Thiazide diuretics have exacerbated or activated systemic lupus erythematosus and this possibility should be considered with metolazone tablets, USP. Information For Patients Patients should be informed of possible adverse effects, advised to take the medication as directed, and promptly report any possible adverse reactions to the treating physician. Drug Interactions Diuretics Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes (see WARNINGS).

Other Antihypertensives When metolazone tablets, USP, are used with other antihypertensive drugs, care must be taken, especially during initial therapy. Dosage adjustments of other antihypertensives may be necessary. Alcohol, Barbiturates, And Narcotics The hypotensive effects of these drugs may… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 117 words ▾

Principal Display Panel 58657-0740-01 Metolazone Tablets, USP 2.5mg 100 tablets Rx Only 58657-0740-10 Metolazone Tablets, USP 2.5mg 1000 tablets Rx Only 58657-0741-01 Metolazone Tablets, USP 5mg 100 tablets Rx Only 58657-0741-10 Metolazone Tablets, USP 5 mg 1000 tablets Rx Only 58657-0742-01 Metolazone Tablets, USP 10 mg 100 tablets Rx Only 58657-0742-10 Metolazone Tablets, USP 10 mg 1000 tablets Rx Only 58657-940-01 Metolazone Tablets, USP 2.5 mg 100 tablets (10 x 10 Unit Dose) Rx Only 58657-941-01 Metolazone Tablets, USP 5 mg 100 tablets (10 x 10 Unit Dose) Rx Only 58657-942-01 Metolazone Tablets, USP 10 mg 100 tablets (10 x 10 Unit Dose) Rx Only 740-01 740-10 741-01 741-10 742-02 741-10 940-01 940-blister 941-01 941-blister 942-01-label 942-blister

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Metolazone — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Metolazone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.81M
Claims incl. refills
143.6K
Beneficiaries
90.5K
Spend / beneficiary
$31.03
Spend / claim
$19.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 58657-0940-01 · Method 58657-0942-01 · Method →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.