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acetazolamide 250 mg Tablet, 100-count — NDC 23155-0288-01 package photo

acetazolamide 250 mg Tablet, 100-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 100 TABLET in 1 BOTTLE (23155-288-01)
NDC 23155-0288-01
🏷️ FDA NDC (as labeled) 23155-288-01 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 $0.3735/unit · Part D plans $0.2706/unit — full pricing hub ↓
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 →
⚠️
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) 23155-288-01
Product NDC 23155-288
11-digit billing NDC 23155028801
NCPDP billing unit EA — each (per item)
RxCUI 197303, 197304
UNII O3FX965V0I
UPC 0323155288018, 0323155288100, 0323155287011, 0323155287103
Application # ANDA205530
SPL Set ID 0700a910-79aa-4431-aecf-637fe14fcae8
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 2016-10-27
Route ORAL
Dosage form TABLET
Substance ACETAZOLAMIDE
GPI-14 37100010000310
GPI class 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 23155-288-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 23155-0288-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderHERITAGE PHARMA LABS INC
FDA applicationANDA205530 (ANDA)
Labeler code23155
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio253 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
📗 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.

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

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

7 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.

💲 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 $0.3735 $37.35 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2706 $27.06 / 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 mgthis 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 mg 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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 23155-0288-01, 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
6.7K
Units reimbursed last 4 qtrs
694.4K
Gross reimbursed last 4 qtrs
$259.4K
Avg / prescription
$38.45
Avg / unit
$0.3735
Latest quarter Q1 2026
1.5KRx
Medicaid pays / ea
$0.3735
gross reimbursed
vs
NADAC / ea
$0.1340
acquisition cost
=
Spread
+$0.2395
+179% 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 ⓘ
27% FFS 73% MCO
Fee-for-service · 1,844 Rx Managed care · 4,902 Rx
State Medicaid map
Alaska: 1,006 units · 137 per 100k residents AK Maine: 14,089 units · 1,010 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 4,709 units · 46.9 per 100k residents MI New York: 33,421 units · 171 per 100k residents NY Vermont: no data reported VT New Hampshire: 6,184 units · 441 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 4,656 units · 37.1 per 100k residents IL Indiana: no data reported IN Ohio: 5,112 units · 43.4 per 100k residents OH Pennsylvania: 4,160 units · 32.1 per 100k residents PA New Jersey: 9,257 units · 99.6 per 100k residents NJ Massachusetts: 152,369 units · 2,176 per 100k residents MA California: 12,964 units · 33.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 2,886 units · 46.6 per 100k residents MO Kentucky: 23,843 units · 527 per 100k residents KY West Virginia: 5,866 units · 331 per 100k residents WV Virginia: 94,963 units · 1,090 per 100k residents VA Maryland: 17,764 units · 287 per 100k residents MD Connecticut: 37,227 units · 1,029 per 100k residents CT Rhode Island: 24,329 units · 2,222 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 12,890 units · 181 per 100k residents TN North Carolina: 117,036 units · 1,080 per 100k residents NC South Carolina: 42,168 units · 785 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,820 units · 83.5 per 100k residents LA Mississippi: no data reported MS Alabama: 8,912 units · 174 per 100k residents AL Georgia: 32,294 units · 293 per 100k residents GA D.C.: 11,009 units · 1,621 per 100k residents DC Hawaii: no data reported HI Texas: 5,399 units · 17.7 per 100k residents TX Florida: 574 units · 2.5 per 100k residents FL
Units reimbursed · per 100k residents
2.52,222
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 Rhode Island 2,222 /100k
2 Massachusetts 2,176 /100k
3 D.C. 1,621 /100k
4 Virginia 1,090 /100k
5 North Carolina 1,080 /100k
6 Connecticut 1,029 /100k
7 Maine 1,010 /100k
8 South Carolina 785 /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 page23155-0288-01 6,746 Rx · $259,372
1000 tablets23155-0288-10 No Medicaid data
Drug total (last 4 qtrs): 6,746 Rx · 694,360 units · $259,372 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
23155-0288-01 You're viewing this 100 TABLET in 1 BOTTLE (23155-288-01) $0.1340 / ea $13.40 2016-10-27 Active
23155-0288-10 1000 TABLET in 1 BOTTLE (23155-288-10) — — 2016-10-27 Active

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 23155-0288-01?
NDC 23155-0288-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 23155-0288-01 and NDC 23155-0288-10?
Both are acetazolamide 250 mg Tablet — the drug itself is identical. NDC 23155-0288-01 is the 100-count package, while NDC 23155-0288-10 is the 1000 tablets package.
What NDC number is used to bill for this package of acetazolamide 250 mg Tablet?
Bill NDC 23155-0288-01 — the 11-digit billing format is 23155028801. 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 1,000 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 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 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 1,000 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 1,000 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 uri…

⛔ 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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) 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 161 words ▾

HOW SUPPLIED Acetazolamide Tablets USP, 125 mg are available for oral administration as white to off white, round tablet, debossed HP 287 on one side and scored on other side. They are supplied as follows: Bottles of 100 Tablets NDC 23155-287-01 Bottles of 1,000 Tablets NDC 23155-287-10 Acetazolamide Tablets USP, 250 mg are available for oral administration as white to off white, round tablet, debossed HP 288 on one side and scored in quarters on other side. They are supplied as follows: Bottles of 100 Tablets NDC 23155-288-01 Bottles of 1,000 Tablets NDC 23155-288-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000129US08 Revised: 04/2026 logo

📋 Description 103 words ▾

DESCRIPTION Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in 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: 222.24 Molecular Formula: C 4 H 6 N 4 O 3 S 2 Acetazolamide tablets, USP are available for oral administration each containing 125 mg and 250 mg of acetazolamide respectively.

Additionally, they contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. 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 ↗
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.