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Acetazolamide 500 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 67457-0853-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetazolamide 500 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 67457-853-50 (Billing 67457-0853-50)

by Mylan Institutional LLC · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Acetazolamide 500 mg/5mL Injection, Powder, Lyophilized, For Solution from Mylan Institutional LLC, marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.

NDC 67457-0853-50
🏷️ FDA NDC (as labeled) 67457-853-50 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 →

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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) 67457-853-50
Product NDC 67457-853
11-digit billing NDC 67457085350
NCPDP billing unit EA — each (per item)
RxCUI 307702
UNII 429ZT169UH
Application # ANDA200880
SPL Set ID 521838b0-a10d-495f-a014-f9ff25a6b6f3
Established class (EPC) Carbonic Anhydrase Inhibitor
Mechanism of action Carbonic Anhydrase Inhibitors
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-13
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ACETAZOLAMIDE SODIUM
TE code (Orange Book) AP · RLD · RS

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

GPI-14 37100010102105
GPI class acetaZOLAMIDE Sodium
GCN Seq No 008163
GCN 34680
HICL code 003640
Ingredient (HICL) Acetazolamide Sodium
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 24:36.04.00
AHFS class Carbonic Anhydrase Inhibitors (24:36)
FDB label name ACETAZOLAMIDE SOD 500 MG VIAL
FDB brand name Acetazolamide Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008163
  • GCN: 34680
  • GPI-14 (Medi-Span): 37100010102105
  • HICL (First Databank): 003640
  • AHFS class code: 24:36.04.00
  • RxCUI (RxNorm): 307702
Why two NDCs? The FDA registers this code as 67457-853-50 — 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 → 67457-0853-50. 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 Inhibitor class.

Pharmacologic class Carbonic Anhydrase Inhibitor
Drug family (ATC) Carbonic anhydrase inhibitors
How it works 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.

Clinical

Label name ACETAZOLAMIDE SOD 500 MG VIAL Ingredient Acetazolamide Sodium
📗 Our plain-language guide HelloPharmacist
  • It is used as an add-on treatment, most commonly for glaucoma. Depending on the product, it is also used for swelling from heart failure, certain seizure disorders, and preventing...
  • Tablets and capsules are taken by mouth, and the injection is given in a vein by a professional. Extended-release capsules for glaucoma are usually taken morning and evening. For m...
  • Tingling in fingers or face, more urination, tiredness, nausea, appetite or taste changes, and drowsiness are among the reported effects. Mention them if they bother you.
  • Call right away if you get a rash, blisters, fever, sore throat, unusual bruising, yellow skin or eyes, confusion, or swelling of the face. Acetazolamide is a sulfa-type drug, and...
📖 Read our full Acetazolamide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

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

🧪 Full Acetazolamide 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1120 $28.127 / J1120 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)67457-853-50
11-digit billing NDC67457-0853-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1120
DescriptorINJECTION, ACETAZOLAMIDE SODIUM, UP TO 500 MG
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 500 MG, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67457-0853-50 You're viewing this Main listing 1 VIAL in 1 CARTON / 5 mL in 1 VIAL 2018-09-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AcetaZOLAMIDE 500 mg 00143-9006-01 Hikma 1 vial — AP FDA listed —
AcetaZOLAMIDE 500 mg 00143-9503-01 Hikma 1 vial — AP FDA listed —
Acetazolamide 500 mg/5mL 23155-0313-31 Heritage 5 ml — AP FDA listed —
Acetazolamide 500 mg/5mL 23155-0831-31 Heritage 1 vial — AP FDA listed —
Acetazolamide 500 mg/5mL 25021-0839-20 Sagent 1 vial — AP FDA listed —
Acetazolamide 500 mg/5mL 39822-0190-01 XGen 1 vial — AP FDA listed —
Acetazolamide 500 mg/5mLthis 67457-0853-50 Mylan 1 vial — AP FDA listed —
Acetazolamide 500 mg/5mL 68083-0661-01 Gland 1 vial — AP 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerMylan Institutional LLC
Application holderMYLAN ASI LLC
FDA applicationANDA200880 (ANDA)
Labeler code67457
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio167 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 🔄 Drug Interactions 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

INDICATIONS AND USAGE 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.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Preparation and Storage of Parenteral Solution Each 500 mg vial containing Acetazolamide for Injection should be reconstituted with at least 5 mL of Sterile Water for Injection prior to use. Reconstituted solutions retain their physical and chemical properties for 3 days under refrigeration at 2° to 8°C (36° to 46°F), or 12 hours at room temperature 20°C to 25°C (68° to 77°F). CONTAINS NO PRESERVATIVE.

The direct intravenous route of administration is preferred. Intramuscular administration is not recommended. Glaucoma: Acetazolamide for injection should be used as an adjunct to the usual therapy.

The dosage employed in the treatment of chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g of acetazolamide for injection per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 1 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension.

Continuous supervision by a physician is advisable. In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma , the preferred dosage is 250 mg every four hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 mg or 250 mg every four hours depending on the individual case.

Intravenous therapy may be used for rapid relief of ocular tension in acute cases. A complementary effect has been noted when acetazolamide for injection has been used in conjunction with miotics or mydriatics as the case demanded. Epilepsy: It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage.

The best results to date have been seen in petit mal in pediatric patients. Good results, however, have been seen in patients, both pediatric patients and adult, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 mg to 30 mg per kg in divided doses.

Although some patients respond to a low dose, the optimum range appears to be from 375 mg to 1000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When acetazolamide for injection is given in combination with other anticonvulsants, it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications.

This can be increased to levels as indicated above. The change from other medications to acetazolamide for injection should be gradual and in accordance with usual practice in epilepsy therapy. Congestive Heart Failure: For diuresis in congestive heart failure, the starting dose is usually 250 mg to 375 mg once daily in the morning (5 mg/kg).

If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day. Acetazolamide for injection yields best diuretic results when given on alternate days, or for two days alternating with a day of rest. Failures in therapy may be due to overdosage or too frequent dosage.

The use of acetazolamide for injection does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction. Drug-Induced Edema: Recommended dosage is 250 mg to 375 mg of acetazolamide for injection once a day for one or two days, alternating with a day of rest. Note: The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 111 words ▾

CONTRAINDICATIONS Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.

It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. Long-term administration of acetazolamide is contraindicated in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

⚠️ Warnings 81 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, and anaphylaxis. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug.

Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.

🤒 Adverse Reactions 166 words ▾

ADVERSE REACTIONS Body as a whole: Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis Digestive: Gastrointestinal disturbances such as nausea, vomiting, diarrhea Hematological/Lymphatic: Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, thrombocytopenic purpura, melena Hepato-biliary disorders: Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis Metabolic/Nutritional: Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia Nervous: Drowsiness, paraesthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions, dizziness Skin: Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis Otologic : Hearing disturbances, tinnitus Eye Disorders: choroidal effusion, choroidal detachment, transient myopia.

Transient myopia is the result of forward movement of the ciliary body leading to a narrowing of the angle. Urogenital: Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure, polyuria To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 191 words ▾

Drug Interactions Aspirin – See WARNINGS . Acetazolamide modifies phenytoin metabolism with increased serum levels of phenytoin. This may increase or enhance the occurrence of osteomalacia in some patients receiving chronic phenytoin therapy.

Caution is advised in patients receiving chronic concomitant therapy. By decreasing the gastrointestinal absorption of primidone, acetazolamide may decrease serum concentrations of primidone and its metabolites, with a consequent possible decrease in anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of acetazolamide in patients receiving primidone.

Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not advisable. Acetazolamide may increase the effects of other folic acid antagonists. Acetazolamide may increase or decrease blood glucose levels.

Consideration should be taken in patients being treated with antidiabetic agents. Acetazolamide decreases urinary excretion of amphetamine and may enhance the magnitude and duration of their effect. Acetazolamide reduces urinary excretion of quinidine and may enhance its effect.

Acetazolamide may prevent the urinary antiseptic effect of methenamine. Acetazolamide increases lithium excretion and the lithium may be decreased. Acetazolamide and sodium bicarbonate used concurrently increases the risk of renal calculus formation.

Acetazolamide may elevate cyclosporine levels.

🧒 Pediatric Use 30 words ▾

Pediatric Use The safety and effectiveness of acetazolamide in pediatric patients have not been established. Growth retardation has been reported in children receiving long-term therapy, believed secondary to chronic acidosis.

🧓 Geriatric Use 97 words ▾

Geriatric Use Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function. Clinical studies of acetazolamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 94 words ▾

OVERDOSAGE No specific antidote is known. Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur.

Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate.

Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide is dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema). Acetazolamide is not a mercurial diuretic. Rather, it is a nonbacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic sulfonamides.

Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain nonglaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g, epilepsy).

Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The diuretic effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid. The result is renal loss of HCO 3 ion, which carries out sodium, water, and potassium.

Alkalinization of the urine and promotion of diuresis are thus affected. Alteration in ammonia metabolism occurs due to increased reabsorption of ammonia by the renal tubules as a result of urinary alkalinization. Placebo-controlled clinical trials have shown that prophylactic administration of acetazolamide at a dose of 250 mg every eight to 12 hours (or a 500 mg controlled-release capsule once daily) before and during rapid ascent to altitude results in fewer and/or less severe symptoms (such as headache, nausea, shortness of breath, dizziness, drowsiness, and fatigue) of acute mountain sickness (AMS).

Pulmonary function (e.g., minute ventilation, expired vital capacity, and peak flow) is greater in the acetazolamide treated group, both in subjects with AMS and asymptomatic subjects. The acetazolamide treated climbers also had less difficulty in sleeping.

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED Acetazolamide for injection, USP (lyophilized) powder is supplied as follows: NDC Strength Package Factor 67457-853-50 500 mg/vial 1 vial per carton Store drug product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store reconstituted solution in a refrigerator between 2° and 8°C (36° and 46°F). Use within 12 hours of reconstitution. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India FEBRUARY 2025 50103682

📋 Description 115 words ▾

DESCRIPTION Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white, crystalline powder, sparingly soluble in practically boiling water, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N -(5-Sulamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure: Acetazolamide for injection, USP is available for intravenous use, and is supplied as a sterile, white or almost white to faintly yellowish white lyophilized powder or plug requiring reconstitution.

Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide, USP. The bulk solution is adjusted to pH 9.2 using sodium hydroxide and, if necessary, hydrochloric acid prior to lyophilization. Acetazolamide Chemical Structure

💬 Information for Patients ~1 min read ▾

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. Caution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted. In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, acetazolamide, which may precipitate or aggravate acidosis, should be used with caution.

Gradual ascent is desirable to try to avoid acute mountain sickness. If rapid ascent is undertaken and acetazolamide is used, it should be noted that such use does not obviate the need for prompt descent if severe forms of high altitude sickness occur, i.e., high altitude pulmonary edema (HAPE) or high altitude cerebral edema. Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported (see WARNINGS ).

Both increases and decreases in blood glucose levels have been described in patients treated with acetazolamide. This should be taken into consideration in patients with impaired glucose tolerance or diabetes mellitus. Acetazolamide treatment may cause electrolyte imbalances, including hyponatremia and hypokalemia, as well as metabolic acidosis.

Therefore, periodic monitoring of serum electrolytes is recommended. Particular caution is recommended in patients with conditions that are associated with, or predispose a patient to, electrolyte and acid/base imbalances, such as patients with impaired renal function (including elderly patients; see PRECAUTIONS, Geriatric Use ), patients with diabetes mellitus, and patients with impaired alveolar ventilation. Some adverse reactions to acetazolamide, such as drowsiness, fatigue, and myopia, may impair the ability to drive and operate machinery.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paresthesia. Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure.

Choroidal effusion and choroidal detachment have been reported after the use of acetazolamide in the post-operative period following ophthalmic surgery. Discontinue Acetazolamide if choroidal effusion and/or choroidal detachment is suspected. 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.

Caution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted. In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, acetazolamide, which may precipitate or aggravate acidosis, should be used with caution. Gradual ascent is desirable to try to avoid acute mountain sickness.

If rapid ascent is undertaken and acetazolamide is used, it should be noted that such use does not obviate the need for prompt descent if severe forms of high altitude sickness occur, i.e., high altitude pulmonary edema (HAPE) or high altitude cerebral edema. Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported (see WARNINGS ). Both increases and decreases in blood glucose levels have been described in patients treated with acetazolamide.

This should be taken into consideration in patients with impaired glucose tolerance or diabetes mellitus. Acetazolamide treatment may cause electrolyte imbalances, including hyponatremia and hypokalemia, as well as metabolic acidosis. Therefore, periodic monitoring of serum electrolytes is recommended.

Particular caution is recommended in patients with conditions that are associated with, or predispose a patient to, electrolyte and acid/base imbalances, such as patients with impaired renal function (including elderly patients; see PRECAUTIONS, Geriatric Use ), patients with diabetes mellitus, and patients with impaired alveolar ventilation. Some adverse reactions to acetazolamide, such as drowsiness, fatigue, and myopia, may impair the ability to drive and operate machinery. Laboratory Tests To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating acetazolamide therapy and at regular intervals during therapy.

If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is recommended. Drug Interactions Aspirin – See WARNINGS .

Acetazolamide modifies phenytoin metabolism with increased serum levels of phenytoin. This may increase or enhance the occurrence of osteomalacia in some patients receiving chronic phenytoin therapy. Caution is advised in patients receiving chronic concomitant therapy.

By decreasing the gastrointestinal absorption of primidone, acetazolamide may decrease serum concentrations of primidone and its metabolites, with a consequent possible decrease in anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of acetazolamide in patients receiving primidone. Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not advisable.

Acetazolamide may increase the effects of other folic acid antagonists. Acetazolamide may increase or decrease blood glucose levels. Consideratio… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 59 words ▾

Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from acetazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother. Acetazolamide should only be used by nursing women if the potential benefit justifies the potential risk to the child.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate the carcinogenic potential of acetazolamide have not been conducted. In a bacterial mutagenicity assay, acetazolamide was not mutagenic when evaluated with and without metabolic activation. The drug had no effect on fertility when administered in the diet to male and female rats at a daily intake of up to 4 times the recommended human dose of 1000 mg in a 50 kg individual.

📄 Package Label / Principal Display Panel 135 words ▾

PRINCIPAL DISPLAY PANEL – 500 mg NDC 67457-853-50 AcetaZOLAMIDE for Injection, USP 500 mg* For Intravenous Use Sterile Mylan ® Rx only One Vial Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. *Each vial contains: acetazolamide sodium equivalent to 500 mg acetazolamide, USP and pH adjusted to approximately 9.6 with sodium hydroxide and, if necessary, hydrochloric acid. Usual Dosage: See package insert for dosage information.

Must be reconstituted. See package insert. Store drug product at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store reconstituted solution in a refrigerator between 2º and 8ºC (36º and 46ºF).

Use within 12 hours of reconstitution. Discard unused portion. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in India Code No.: KR/DRUGS/KTK/28/384/2009 Mylan.com Acetazolamide for Injection 500 mg Carton Label

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 Acetazolamide — the program that covers self-administered drugs. 12 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 Acetazolamide. 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
$2.17M
Claims incl. refills
65K
Beneficiaries
44.5K
Spend / beneficiary
$48.76
Spend / claim
$33.33
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 Acetazolamide (this brand).

Top reported reactions

Condition Aggravated301
Headache287
Fatigue256
Dyspnoea253
Nausea251
Metabolic Acidosis208
Diarrhoea179

Age at onset

Neonate29
Infant20
Child64
Adolescent82
Adult534
Elderly290

Reporter sex

6,026 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization2,144
Death468
Life-threatening392
Disabling152
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 668 300
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Mylan Institutional LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mylan Institutional LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1120 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 67457-0852-04 · Mylan 67457-0854-04 · Mylan →
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.