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Acetazolamide 250 mg Tablet, 100-count — NDC 64380-0834-06 package photo

Acetazolamide 250 mg Tablet, 100-count

by Strides Pharma Science Limited · 100 TABLET in 1 BOTTLE (64380-834-06)
NDC 64380-0834-06
🏷️ FDA NDC (as labeled) 64380-834-06 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1340 NADAC Per package$13.40 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2958/unit · Part D plans $0.3683/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Acetazolamide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 24, 2024 — Discoloration (Rubicon Research Private Limited) · FDA recall D-0659-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 64380-834-06
Product NDC 64380-834
11-digit billing NDC 64380083406
NCPDP billing unit EA — each (per item)
RxCUI 197303, 197304
UNII O3FX965V0I
UPC 0364380834069, 0364380833062
Application # ANDA209734
SPL Set ID 4813b9dd-5f58-44bb-ad64-cdb331828080
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 2017-11-20
Route ORAL
Dosage form TABLET
Substance ACETAZOLAMIDE
GCN Seq No 008166
GCN 34722
HICL code 003641
Ingredient (HICL) Acetazolamide
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 250 MG TABLET
FDB brand name Acetazolamide
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 64380-834-06 — 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 → 64380-0834-06. 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.

🏭 Manufacturer & labeler

LabelerStrides Pharma Science Limited
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA209734 (ANDA)
Labeler code64380
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio195 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 ACETAZOLAMIDE 250 MG TABLET Ingredient Acetazolamide
📖 What it is MedlinePlus · NLM

Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Acetazolamide decreases the pressure in the eye. Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain) sickness. Acetazolamide is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Acetazolamide is used for several different things, depending on the form your doctor prescribed. It can help lower eye pressure in glaucoma, reduce certain types of seizures, trea...
  • What conditions is acetazolamide actually used for?
  • The most common things people notice are tingling or numbness in the hands, feet, or face, more frequent urination, tiredness, nausea, dizziness, and loss of appetite. These are ge...
  • What side effects should I expect, and which ones mean I should call my doctor?
📖 Read our full Acetazolamide guide →
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.

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.

🧪 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 $0.134 $13.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2958 $29.58 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.3683 $36.83 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.321 $0.123
▼ Down 53% over the last 24 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
acetazolamide 250 mg 00904-6663-61 Major 100 tablets $0.134 AB Availability likely —
acetazolamide 250 mg 23155-0288-01 Heritage 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 50268-0054-15 AvPAK 50 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 59651-0906-01 Aurobindo 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 62135-0608-12 Chartwell 120 tablets $0.134 AB Availability likely —
Acetazolamide 250 mgthis 64380-0834-06 Strides 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 70756-0721-11 Lifestar 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 71930-0009-12 Eywa 100 tablets $0.134 AB Availability likely —
acetaZOLAMIDE 250 mg 72578-0150-01 Viona 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 72888-0048-01 Advagen 100 tablets $0.134 AB Availability likely —
Acetazolamide 250 mg 10135-0831-01 Marlex 100 tablets — AB FDA listed —
Acetazolamide 250 mg 27241-0133-04 Ajanta 100 tablets — — FDA listed —
acetazolamide 250 mg 42291-0090-01 AvKARE 100 tablets — AB FDA listed —
Acetazolamide 250 mg 50090-5593-00 A-S 12 tablets — AB FDA listed —
acetaZOLAMIDE 250 mg 50090-7536-00 A-S 12 tablets — AB FDA listed —
Acetazolamide 250 mg 52817-0201-00 TRUPHARMA, 1000 tablets — AB FDA listed —
Acetazolamide 250 mg 63629-1195-01 Bryant 100 tablets — AB FDA listed —
acetaZOLAMIDE 250 mg 70710-1239-01 Zydus 100 tablets — AB FDA listed —
acetaZOLAMIDE 250 mg 70771-1828-01 Zydus 100 tablets — AB FDA listed —
Acetazolamide 250 mg 70954-0034-20 ANI 1000 tablets — AB FDA listed —
Acetazolamide 250 mg 71335-2215-01 Bryant 100 tablets — AB FDA listed —
Acetazolamide 250 mg 72162-1979-01 Bryant 100 tablets — AB FDA listed —
Acetazolamide 250 mg 72789-0237-01 PD-Rx 100 tablets — AB FDA listed —
Acetazolamide 250 mg 81005-0105-01 Aarkish 100 tablets — AB FDA listed —
Acetazolamide 250 mg 87448-1601-01 Northwestern 1 tablet — AB Discontinued —
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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64380-0834-06, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
28.9K
Units reimbursed last 4 qtrs
2.7M
Gross reimbursed last 4 qtrs
$790.4K
Avg / prescription
$27.31
Avg / unit
$0.2958
Latest quarter Q1 2026
6.3KRx
Medicaid pays / ea
$0.2958
gross reimbursed
vs
NADAC / ea
$0.1340
acquisition cost
=
Spread
+$0.1618
+121% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 11,214 Rx Managed care · 17,727 Rx
State Medicaid map
Alaska: 3,314 units · 452 per 100k residents AK Maine: 21,814 units · 1,564 per 100k residents ME Washington: 75,397 units · 965 per 100k residents WA Idaho: 14,583 units · 743 per 100k residents ID Montana: 15,928 units · 1,407 per 100k residents MT North Dakota: 2,044 units · 261 per 100k residents ND Minnesota: 55,005 units · 959 per 100k residents MN Wisconsin: 88,538 units · 1,498 per 100k residents WI Michigan: 87,232 units · 869 per 100k residents MI New York: 185,068 units · 946 per 100k residents NY Vermont: 14,553 units · 2,249 per 100k residents VT New Hampshire: 14,749 units · 1,052 per 100k residents NH Oregon: 68,153 units · 1,610 per 100k residents OR Nevada: 21,111 units · 661 per 100k residents NV Wyoming: 3,356 units · 575 per 100k residents WY South Dakota: 5,064 units · 551 per 100k residents SD Iowa: 28,758 units · 897 per 100k residents IA Illinois: 138,505 units · 1,104 per 100k residents IL Indiana: 59,894 units · 873 per 100k residents IN Ohio: 103,424 units · 878 per 100k residents OH Pennsylvania: 85,388 units · 659 per 100k residents PA New Jersey: 37,949 units · 408 per 100k residents NJ Massachusetts: 36,821 units · 526 per 100k residents MA California: 232,258 units · 596 per 100k residents CA Utah: 14,016 units · 410 per 100k residents UT Colorado: 76,938 units · 1,309 per 100k residents CO Nebraska: 16,993 units · 859 per 100k residents NE Missouri: 78,664 units · 1,270 per 100k residents MO Kentucky: 93,665 units · 2,069 per 100k residents KY West Virginia: 31,423 units · 1,775 per 100k residents WV Virginia: 50,801 units · 583 per 100k residents VA Maryland: 42,669 units · 690 per 100k residents MD Connecticut: 24,658 units · 682 per 100k residents CT Rhode Island: 8,017 units · 732 per 100k residents RI Arizona: 66,503 units · 895 per 100k residents AZ New Mexico: 37,747 units · 1,786 per 100k residents NM Kansas: 10,847 units · 369 per 100k residents KS Arkansas: 26,914 units · 878 per 100k residents AR Tennessee: 78,516 units · 1,102 per 100k residents TN North Carolina: 164,476 units · 1,518 per 100k residents NC South Carolina: 17,863 units · 332 per 100k residents SC Delaware: 10,943 units · 1,061 per 100k residents DE Oklahoma: 34,700 units · 856 per 100k residents OK Louisiana: 121,772 units · 2,662 per 100k residents LA Mississippi: 26,575 units · 904 per 100k residents MS Alabama: 33,991 units · 665 per 100k residents AL Georgia: 33,778 units · 306 per 100k residents GA D.C.: 2,608 units · 384 per 100k residents DC Hawaii: no data reported HI Texas: 93,559 units · 307 per 100k residents TX Florida: 63,790 units · 282 per 100k residents FL
Units reimbursed · per 100k residents
2612,662
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 2,662 /100k
2 Vermont 2,249 /100k
3 Kentucky 2,069 /100k
4 New Mexico 1,786 /100k
5 West Virginia 1,775 /100k
6 Oregon 1,610 /100k
7 Maine 1,564 /100k
8 North Carolina 1,518 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page64380-0834-06 28,941 Rx · $790,358
1000 tablets64380-0834-46 No Medicaid data
Drug total (last 4 qtrs): 28,941 Rx · 2,671,563 units · $790,358 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64380-0834-06 You're viewing this 100 TABLET in 1 BOTTLE (64380-834-06) $0.1340 / ea $13.40 2017-11-20 Active
64380-0834-46 1000 TABLET in 1 BAG (64380-834-46) — — 2017-11-20 Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 64380-0834-06?
NDC 64380-0834-06 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 64380-0834-06 and NDC 64380-0834-46?
Both are Acetazolamide 250 mg Tablet — the drug itself is identical. NDC 64380-0834-06 is the 100-count package, while NDC 64380-0834-46 is the 1000 tablets package.
What NDC number is used to bill for this package of Acetazolamide 250 mg Tablet?
Bill NDC 64380-0834-06 — the 11-digit billing format is 64380083406. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 81 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. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Glaucoma: Acetazolamide 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 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 or 250 mg every four hours depending on the individual case. A complementary effect has been noted when acetazolamide 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 to 30 mg per kg in divided doses.

Although some patients respond to a low dose, the optimum range appears to be from 375 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 tablets are 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 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 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 tablets yield 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 does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction. Drug-Induced Edema: Recommended dosage is 250 to 375 mg of acetazolamide once a day for one or two days, alternating with a day of rest. Acute Mountain Sickness: Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or sustained-release capsules as appropriate.

In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms. 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 kidney which requires intermittent dosage if it is to recover from the inhibitory effect of the therapeutic agent.

Interference with Laboratory Tests Sulfonamides may give false negative or decreased values for urinary phenolsulfonphthalein and phenol red elimination values for urinary…

⛔ 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 ~1 min read ▾

ADVERSE REACTIONS Body as a whole: Headache, malaise, fatigue, fever, 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 Postmarketing Experience: The following adverse reactions have been identified during post approval use of acetazolamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory, thoracic and mediastinal disorders: Non-cardiogenic pulmonary edema has been reported following cataract surgery. To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 52 words ▾

Pregnancy: Teratogenic effects Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters, and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 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.

🆘 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 (eg, some types of glaucoma), in the treatment of certain convulsive disorders (eg, epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (eg, 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 (eg, 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 (eg, 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 103 words ▾

HOW SUPPLIED Acetazolamide Tablets USP are supplied as follows: 125 mg – White to off white, round, flat, uncoated tablet, debossed as "S;571" on one side and scored in half on other side NDC 64380-833-06 - Bottle of 100 250 mg – White to off white, round, biconvex, uncoated tablet, debossed as "S;572" on one side and scored in quarters on other side NDC 64380-834-06 - Bottle of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Strides Pharma Science Ltd. Puducherry - 605 014, India.

Distributed by: Strides Pharma Inc Bridgewater, NJ 08807 Revised: 12/2025

📋 Description 100 words ▾

DESCRIPTION Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, very slightly soluble in water, sparingly soluble in practically boiling water and slightly soluble in alcohol. The chemical name for acetazolamide is N -(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure: Molecular Weight: 222.25 Molecular Formula: C 4 H 6 N 4 O 3 S 2 Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: corn starch, gelatin, glycerin, lactose monohydrate, magnesium stearate, sodium starch glycolate (Potato) and talc. acetazolamide-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 tablets are used, it should be noted that such use does not obviate the need for prompt descent if severe forms of high altitude sickness occur, ie, 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.

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