Prescription medicine
Acetohydroxamic acid Brand names: Lithostat
Acetohydroxamic acid (Lithostat) is a prescription medicine with an FDA approval on record since 1983. No generic is listed; pharmacies paid $6.66 per Lithostat 250 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the acetohydroxamic acid FDA label on DailyMed (effective January 8, 2026, Mission Pharmacal Company); the NDA 18749 record on Drugs@FDA; every acetohydroxamic acid label on DailyMed.
Highlights of the record
FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAcetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection.
Forms and strengths
- 250 mg
Tablet.
On the market
- Earliest approval on file
- May 31, 1983 Lithostat, Mission Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.66 per tablet Lithostat 250 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 47 through July 30, 2026
What is acetohydroxamic acid used for?
From the label: indications and usageAcetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used in lieu of curative surgical treatment (for patients with stones) or antimicrobial treatment. Long-term treatment with AHA may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with AHA does not go beyond 7 years. A patient package insert should be distributed to each patient who receives AHA.
FDA pharmacologic class: Urease Inhibitor.
Source: FDA drug label (Lithostat), Mission Pharmacal Company, effective January 8, 2026 (SPL set 6660b616-a82d-9109-19ce-2bdf9747acea), via openFDA; the full label on DailyMed
Is there a generic for acetohydroxamic acid (Lithostat)?
No generic acetohydroxamic acid is approved (Drugs@FDA, October 8, 2026).
- 1983 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetohydroxamic acid (Lithostat)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.66 per Lithostat 250 mg tablet, down 7% from $7.16 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lithostat 250 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lithostat 250 mg tablet | Brand | $6.66 per tablet | $199.90 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for acetohydroxamic acid?
The FDA Adverse Event Reporting System holds 47 reports that list acetohydroxamic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 6 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Acetohydroxamic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other