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Methazolamide 25 mg Tablet, 100-count

by Precision Dose, Inc. · 100 TABLET in 1 BOTTLE (68094-908-50)
NDC 68094-0908-50
🏷️ FDA NDC (as labeled) 68094-908-50 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68094-908-50
Product NDC 68094-908
11-digit billing NDC 68094090850
NCPDP billing unit EA — each (per item)
RxCUI 197939, 197940
UNII W733B0S9SD
Application # ANDA215615
SPL Set ID 1e0e81c7-a328-4034-a6b3-4c83e9ac3a3e
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-30
Route ORAL
Dosage form TABLET
Substance METHAZOLAMIDE
GPI-14 37100030000303
GCN Seq No 008168
GCN 34741
HICL code 003643
Ingredient (HICL) Methazolamide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1E
Therapeutic class — specific (HIC3) Carbonic Anhydrase Inhibitors
AHFS code 52:40.12.00
AHFS class Carbonic Anhydrase Inhibitors (52:40)
FDB label name METHAZOLAMIDE 25 MG TABLET
FDB brand name Methazolamide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68094-908-50 — 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 → 68094-0908-50. 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 Carbonic anhydrase inhibitors class.

Drug family (ATC) Carbonic anhydrase inhibitors
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.

🏭 Manufacturer & labeler

LabelerPrecision Dose, Inc.
Application holderTAGI PHARMA INC
FDA applicationANDA215615 (ANDA)
Labeler code68094
First marketedNov 2023
Product typeHuman Prescription Drug
Portfolio54 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.

🩺 Clinical

Label name METHAZOLAMIDE 25 MG TABLET Ingredient Methazolamide
📗 Our plain-language guide HelloPharmacist
  • It's reducing the pressure inside your eye. Your eye constantly makes a fluid called aqueous humor, and methazolamide slows down how much of that fluid is produced. Less fluid mean...
  • What is methazolamide actually doing for my eyes?
  • The most common one people notice is a tingling or 'pins and needles' feeling in their hands and feet — it can be a little odd but it's well known with this type of drug. You might...
  • What side effects should I actually expect when I start taking it?
📖 Read our full Methazolamide guide →
7
Nutrient depletion considerations

Methazolamide may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color White
ShapeRound
Imprint50;ZEN
Size7 mm
ScoringScored — splits in 2
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.

💲 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 $0.628 $62.75 / 100 tablets
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 $1.59 $159.26 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.985 $0.628
▼ Down 36% over the last 10 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
methazolamide 25 mg 00574-0790-01 Padagis 100 tablets $0.627 AB Availability likely —
Methazolamide 25 mg 62559-0240-01 ANI 100 tablets $0.627 AB Availability likely —
Methazolamide 25 mgthis 68094-0908-50 Precision 100 tablets $0.627 AB Availability likely —
Methazolamide 25 mg 72603-0166-01 NorthStar 100 tablets $0.627 AB Availability likely —
Methazolamide 25 mg 24208-0022-01 Bausch 1000 tablets — AB FDA listed —
Methazolamide 25 mg 27241-0246-01 Ajanta 100 tablets — AB FDA listed —
Methazolamide 25 mg 42571-0239-05 Micro 500 tablets — AB FDA listed —
Methazolamide 25 mg 51407-0026-01 Golden 100 tablets — AB FDA listed —
Methazolamide 25 mg 63629-1986-01 Bryant 100 tablets — AB FDA listed —
Methazolamide 25 mg 72162-1754-01 Bryant 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
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.

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

Medicare Part D (outpatient prescription) spending for Methazolamide — the program that covers self-administered drugs. 5 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 Methazolamide. 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
$2.31M
Claims incl. refills
11.6K
Beneficiaries
6.5K
Spend / beneficiary
$352.44
Spend / claim
$198.87
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Methazolamide — the ingredient across all brands.

Top reported reactions

Fatigue41
Dizziness29
Dyspnoea28
Headache28
Blood Pressure Increased22
Asthenia21
Anxiety20

Age at onset

Adult28
Elderly31

Reporter sex

339 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization89
Death28
Life-threatening9
Disabling8
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 34 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68094-0908-50 You're viewing this 100 TABLET in 1 BOTTLE (68094-908-50) 2023-11-30 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 47 words ▾

INDICATIONS AND USAGE Methazolamide Tablets, USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.

⏱️ Dosage and Administration 31 words ▾

DOSAGE AND ADMINISTRATION The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.

⛔ Contraindications 71 words ▾

CONTRAINDICATIONS Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the development of hepatic encephalopathy. Long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

⚠️ Warnings 89 words ▾

WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration. If hypersensitivity or other serious reactions occur, the use of this drug should be discontinued.

Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma, and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors.

🤒 Adverse Reactions 133 words ▾

ADVERSE REACTIONS Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a "tingling" feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting, and diarrhea; polyuria; and occasional instances of drowsiness and confusion. Metabolic acidosis and electrolyte imbalance may occur. Transient myopia has been reported.

This condition invariably subsides upon diminution or discontinuance of the medication. Other occasional adverse reactions include urticaria, melena, hematuria, glycosuria, hepatic insufficiency, flaccid paralysis, photosensitivity, convulsions, and, rarely, crystalluria and renal calculi. Also see PRECAUTIONS: Information for Patients for possible reactions common to sulfonamide derivatives.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS ).

🔄 Drug Interactions 54 words ▾

Drug Interactions Methazolamide should be used with caution in patients on steroid therapy because of the potential for developing hypokalemia. Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors (see WARNINGS ).

🤰 Pregnancy 53 words ▾

Pregnancy Teratogenic effects Methazolamide has been shown to be teratogenic (skeletal anomalies) in rats when given in doses approximately 40 times the human dose. There are no adequate and well controlled studies in pregnant women. Methazolamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 15 words ▾

Pediatric Use The safety and effectiveness of methazolamide in pediatric patients have not been established.

🆘 Overdosage 85 words ▾

OVERDOSAGE No data are available regarding methazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that even a high dose of methazolamide is nontoxic. No specific antidote is known.

Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and central nervous system effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

Supportive measures may be required to restore electrolyte and pH balance.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Methazolamide is a potent inhibitor of carbonic anhydrase. Methazolamide is well absorbed from the gastrointestinal tract. Peak plasma concentrations are observed 1 to 2 hours after dosing.

In a multiple-dose, pharmacokinetic study, administration of methazolamide 25 mg BID, 50 mg BID, and 100 mg BID demonstrated a linear relationship between plasma methazolamide levels and methazolamide dose. Peak plasma concentrations (Cmax) for the 25 mg, 50 mg and 100 mg BID regimens were 2.5 mcg/mL, 5.1 mcg/mL, and 10.7 mcg/mL, respectively. The area under the plasma concentration-time curves (AUC) were 1130 mcg.min/mL, 2571 mcg.min/mL, and 5418 mcg.min/mL for the 25 mg, 50 mg, and 100 mg dosage regimens, respectively.

Methazolamide is distributed throughout the body including the plasma, cerebrospinal fluid, aqueous humor of the eye, red blood cells, bile and extracellular fluid. The mean apparent volume of distribution (V area /F) ranges from 17 L to 23 L. Approximately 55% is bound to plasma proteins.

The steady-state methazolamide red blood cell:plasma ratio varies with dose and were found to be 27:1, 16:1, and 10:1 following the administration of methazolamide 25 mg BID, 50 mg BID, and 100 mg BID, respectively. The mean steady-state plasma elimination half-life for methazolamide is approximately 14 hours. At steady-state, approximately 25% of the dose is recovered unchanged in the urine over the dosing interval.

Renal clearance accounts for 20% to 25% of the total clearance of drug. After repeated BID- lid dosing, methazolamide accumulates to steady-state concentrations in 7 days. Methazolamide's inhibitory action on carbonic anhydrase decreases the secretion of aqueous humor and results in a decrease in intraocular pressure.

The onset of the decrease in intraocular pressure generally occurs within 2 to 4 hours, has a peak effect in 6 to 8 hours and a total duration of 10 to 18 hours. Methazolamide is a sulfonamide derivative; however, it does not have any clinically significant antimicrobial properties. Although methazolamide achieves a high concentration in the cerebrospinal fluid, it is not considered an effective anticonvulsant.

Methazolamide has a weak and transient diuretic effect; therefore, use results in an increase in urinary volume, with excretion of sodium, potassium, and chloride. The drug should not be used as a diuretic. Inhibition of renal bicarbonate reabsorption produces an alkaline urine.

Plasma bicarbonate decreases, and a relative, transient metabolic acidosis may occur due to a disequilibrium in carbon dioxide transport in the red blood cell. Urinary citrate excretion is decreased by approximately 40% after doses of 100 mg every 8 hours. Uric acid output has been shown to decrease 36% in the first 24 hour period.

📦 How Supplied / Storage and Handling 107 words ▾

HOW SUPPLIED Methazolamide Tablets USP, 25 mg are white to off white, uncoated, round, biconvex tablets debossed with '25' on one side and 'ZEN' on other side and are supplied in bottles of 100, NDC 68094-908-50. Methazolamide Tablets USP, 50 mg are white to off white, uncoated, round, biconvex tablets debossed with '5 and 0' on either side of the break line one side and 'ZEN' on other side and are supplied in bottles of 100, NDC 68094-808-50. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

📦 Storage and Handling 29 words ▾

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

📋 Description 91 words ▾

DESCRIPTION Methazolamide, a sulfonamide derivative, is a white or faintly yellow, crystalline powder, soluble in dimethyl formamide, slightly soluble in acetone, very slightly soluble in water and alcohol. The chemical name for methazolamide is: Acetamide, N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]- and it has the following structural formula: C5H8N4O3S2 236.26 Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and isopropyl alcohol. lsopropyl alcohol is removed during manufacturing process Chemical Structure

💬 Information for Patients 67 words ▾

Information for Patients Adverse reactions common to all sulfonamide derivatives may occur: anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leukopenia, pancytopenia, and agranulocytosis. Precaution is advised for early detection of such reactions, and the drug should be discontinued and appropriate therapy instituted. Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly.

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