Prescription medicine
Dehydrated alcohol First approved as Ablysinol
Dehydrated alcohol (Ablysinol) is a prescription medicine with an FDA approval on record since 2018. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the dehydrated alcohol FDA label on DailyMed (effective July 11, 2025, Ingenus Pharmaceuticals, LLC); the NDA 207987 record on Drugs@FDA; every dehydrated alcohol label on DailyMed.
Highlights of the record
FDA label of July 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
Forms and strengths
- 5 ml/5ml
Injection (solution).
On the market
- Earliest approval on file
- June 21, 2018 Ablysinol, Bpi Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first June 23, 2025; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2014 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 18 through July 30, 2026
What is dehydrated alcohol used for?
From the label: indications and usageDehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Dehydrated alcohol injection is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
Source: FDA drug label (Dehydrated Alcohol), Ingenus Pharmaceuticals, LLC, effective July 11, 2025 (SPL set 1d5ec6f9-d58f-4651-a4a1-93fec13fd438), via openFDA; the full label on DailyMed
Is there a generic for dehydrated alcohol (Ablysinol)?
The FDA approved the first generic dehydrated alcohol on June 23, 2025. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dehydrated alcohol from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2018 earliest approval on file
- 2025 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has dehydrated alcohol been recalled?
The FDA's Enforcement Report lists 2 recalls naming dehydrated alcohol since 2014: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of dehydrated alcohol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 25, 2018 | Class II | Ranier's Compounding Laboratory not a listed maker | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. |
| December 26, 2014 | Class II | Walgreens Infusion Services not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dehydrated alcohol label say about other medicines?
The dehydrated alcohol label names no other medicine on this site. The labels of 3 other medicines name dehydrated alcohol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name dehydrated alcohol
Source: FDA drug label (Dehydrated Alcohol), Ingenus Pharmaceuticals, LLC, effective July 11, 2025 (SPL set 1d5ec6f9-d58f-4651-a4a1-93fec13fd438), via openFDA; the full label on DailyMed
What do FAERS reports show for dehydrated alcohol?
The FDA Adverse Event Reporting System holds 18 reports that list dehydrated alcohol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 7 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?
- Dehydrated alcohol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other