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Dehydrated Alcohol 1 mL/mL Injection, Solution — NDC 54288-144-10 (Billing 54288-0144-10)

by BPI Labs, LLC · 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of Dehydrated Alcohol 1 mL/mL Injection, Solution from BPI Labs, LLC, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 54288-0144-10
🏷️ FDA NDC (as labeled) 54288-144-10 billing pads the product segment with a zero
Rx only Brand 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 54288-144-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
54288 labeler · 144 product · 10 package
Package marketed since
Apr 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0354288105019
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54288-144-10
Product NDC 54288-144
11-digit billing NDC 54288014410
NCPDP billing unit ML — per mL (volume)
RxCUI 2048979, 2048982
UNII 3K9958V90M
UPC 0354288105019
Application # NDA207987
SPL Set ID 314b1dab-8f4f-49ae-a105-f974842818b8
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route PERCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ALCOHOL

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

GCN Seq No 087780
GCN 57797
HICL code 001681
Ingredient (HICL) Ethyl Alcohol
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A5
Therapeutic class — intermediate (HIC2) Cardiac Treatment Agents, Other
HIC3 code A5B
Therapeutic class — specific (HIC3) Hypertrophic Cardiomyopathy Tx Agents, Ablative
AHFS code 24:12.00.00
AHFS class Sclerosing Agents
FDB label name ABLYSINOL 99% VIAL
FDB brand name Ablysinol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087780
  • GCN: 57797
  • HICL (First Databank): 001681
  • AHFS class code: 24:12.00.00
  • RxCUI (RxNorm): 2048979
Why two NDCs? The FDA registers this code as 54288-144-10 — 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 → 54288-0144-10. 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 Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants, Antidotes, Nerve depressants
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 ABLYSINOL 99% VIAL Ingredient Ethyl Alcohol
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 Read our full Alcohol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54288-0144-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2025-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dehydrated Alcohol 1 mL/mL 16729-0710-45 Accord 10 vials — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 39822-9300-02 XGen 10 ampules — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 50090-7643-00 A-S 1 ampule — AP FDA listed —
Dehydrated Alcohol 5 mL/5mL 50742-0539-10 Ingenus 10 vials — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 51991-0999-17 Breckenridge 10 vials — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 54288-0105-10 BPI 10 ampules — — FDA listed —
Dehydrated Alcohol 1 mL/mLthis 54288-0144-10 BPI 10 vials — — FDA listed —
Dehydrated Alcohol 1 mL/mL 55579-0306-05 Solupharm 5 ml — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 82983-0426-10 Ajenat 10 vials — — FDA listed —
Dehydrated Alcohol 1 mL/mL 83634-0306-05 Avenacy, 5 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🧪 Avoiding an ingredient? See Alcohol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

Manufacturer & labeler

LabelerBPI Labs, LLC
Application holderBPI LABS LLC
FDA applicationNDA207987 (NDA)
Labeler code54288
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from BPI Labs, LLC labeler code 54288

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 65 words ▾

1 INDICATIONS AND USAGE ABLYSINOL ® 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. ABLYSINOL 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. ( 1 )

⏱️ Dosage and Administration 179 words ▾

2 DOSAGE AND ADMINISTRATION Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. ( 2.1 ) In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL. ( 2.1 )

2.1Recommended Dosing Use the minimum dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, guided by assessment of the gradient. In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose of ABLYSINOL that should be used in a single procedure is 5 mL.

2.2Administration ABLYSINOL should only be administered under the supervision of a qualified interventional cardiologist experienced in the percutaneous transluminal septal myocardial ablation procedure. Inspect visually for particulate matter and discoloration prior to administration. ABLYSINOL should appear as a clear, colorless solution.

💊 Dosage Forms and Strengths 95 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mL or 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass ampule. Injection: 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. Injection: 1 mL or 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass ampule.

( 3 ) Injection: 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. (3)

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Transient heart block: Transient heart block is common at the time of injection. A temporary pacing wire is routinely inserted to mitigate transient heart block. (5.1) Persistent heart block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker.

(5.1) Remove the temporary pacemaker lead if no episode of high-degree atrioventricular block occurs. (5.1) Monitor the patient for heart failure, chest pain, and arrhythmias several days after the procedure. (5.1, 5.2 , 5.3 )

5.1Heart Block Transient Heart Block Transient heart block is common at the time of dehydrated alcohol, such as ABLYSINOL, injection into a septal artery. Prior to the injection, a temporary pacing wire is routinely inserted into the apex of the right ventricle, usually via the femoral vein, to treat transient heart block. The pacing lead can be removed if no episode of high-degree atrioventricular block occurs, usually after several hours of observation following percutaneous transluminal septal myocardial ablation.

Persistent Heart Block Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker following percutaneous transluminal septal myocardial ablation. Risk factors for permanent pacemaker dependency after septal ablation include a baseline PQ interval > 160 ms, baseline minimum heart rate < 50 bpm, baseline left ventricular outflow gradient > 70 mmHg, maximum QRS during the first 48 hours > 155 ms, 3 rd degree atrio-ventricular block occurring during the procedure, and no clinical recovery between 12-48 hours after the procedure.

5.2Myocardial Infarction Injection of dehydrated alcohol is intended to create a controlled myocardial infarction for therapeutic purposes. However, excessive myocardial necrosis and subsequent heart failure have been reported. Factors increasing the risk of excessive tissue necrosis include higher volume of alcohol used and a higher number of septal branches injected to reduce the left ventricular outflow tract gradient.

5.3Ventricular Arrhythmia Ventricular tachycardia and ventricular fibrillation requiring electrocardioversion occurred at a frequency of approximately 1%. Perform continuous electrocardiographic monitoring for 48 hours after the procedure.

🤒 Adverse Reactions 73 words ▾

6 ADVERSE REACTIONS Heart block [ see Warnings and precautions (5.1)] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as ABLYSINOL, were identified in the literature: Ventricular tachycardia and ventricular fibrillation. Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at (727) 471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS ABLYSINOL is not recommended during pregnancy. Maternal use is not expected to result in fetal exposure to the drug. ( 8.1 ) The rate of heart blocks and dysrhythmia increased with age. (8.5) See 17 for PATIENT COUNSELING INFORMATION

8.1Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation. Maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations ABLYSINOL for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy.

When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period. Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human. The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.

8.2Lactation ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation and breastfeeding is not expected to result in exposure of the child to the drug.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥ 60 years old showed similar improvement in exercise capacity after ablation. The rate of heart blocks and dysrhythmia increased with age. Permanent pacemaker dependency increased to 34% in patients > 60 years old.

🤰 Pregnancy 143 words ▾

8.1Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but ABLYSINOL is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation. Maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations ABLYSINOL for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy.

When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period. Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human. The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 57 words ▾

8.5Geriatric Use A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥ 60 years old showed similar improvement in exercise capacity after ablation. The rate of heart blocks and dysrhythmia increased with age. Permanent pacemaker dependency increased to 34% in patients > 60 years old.

🆘 Overdosage 47 words ▾

10 OVERDOSAGE There is a direct correlation between the volume of alcohol and size of iatrogenic myocardial infarction. Stop the procedure if there is failure to reduce the left ventricular outflow tract pressure gradient to less than 10 mmHg when reaching a total dose of 5 mL.

🧬 Clinical Pharmacology 163 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dehydrated alcohol is a tissue toxin that produces a myocardial infarction when injected through an intra-arterial catheter into a target septal vessel, which causes the hypertrophied septum to thin.

12.2Pharmacodynamics A dose independent, approximate 70% reduction of the peak pressure gradient across left ventricular outflow tract is observed after injection of alcohol volumes in the range of 1-4 mL. Remodeling contributes about 20% to the 70% total reduction in peak pressure gradient across the left ventricular outflow tract measured 12 months after septal ablation. Other markers, such as infarct size or peak concentration of creatine kinase-MB (CK-MB), in contrast to peak pressure gradient across the left ventricular outflow tract, vary in proportion to the injected alcohol volume in the 1-4 mL range.

12.3Pharmacokinetics Because injection of ABLYSINOL during septal ablation is not expected to increase the systemic concentrations of endogenous alcohol significantly, the pharmacokinetics of dehydrated alcohol are not expected to be clinically significant.

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action Dehydrated alcohol is a tissue toxin that produces a myocardial infarction when injected through an intra-arterial catheter into a target septal vessel, which causes the hypertrophied septum to thin.

📦 How Supplied / Storage and Handling 81 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ABLYSINOL (dehydrated alcohol) injection is a clear, colorless liquid supplied in clear, glass, single-dose ampules and single-dose vials. Each mL contains 99% by volume ethyl alcohol. Volume NDC Single ampule Carton of 10 ampules 1 mL 54288-105-01 54288-105-10 5 mL 54288-105-02 54288-105-15 Single Vial Carton of 10 Vials 5 mL 54288-144-01 54288-144-10 Store at room temperature, between 20°C and 25°C (68°F and 77°F).

Do not refrigerate or freeze. Highly flammable, store away from any heat source.

📋 Description 75 words ▾

11 DESCRIPTION ABLYSINOL (dehydrated alcohol) injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. ABLYSINOL is for cardiac septal branch intra-arterial use. It has a molecular formula of C 2 H 6 O and a molecular weight of 46.07.

Dehydrated Alcohol Injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula: chemicalstructure

🧬 Pharmacokinetics 33 words ▾

12.3Pharmacokinetics Because injection of ABLYSINOL during septal ablation is not expected to increase the systemic concentrations of endogenous alcohol significantly, the pharmacokinetics of dehydrated alcohol are not expected to be clinically significant.

🧬 Pharmacodynamics 94 words ▾

12.2Pharmacodynamics A dose independent, approximate 70% reduction of the peak pressure gradient across left ventricular outflow tract is observed after injection of alcohol volumes in the range of 1-4 mL. Remodeling contributes about 20% to the 70% total reduction in peak pressure gradient across the left ventricular outflow tract measured 12 months after septal ablation. Other markers, such as infarct size or peak concentration of creatine kinase-MB (CK-MB), in contrast to peak pressure gradient across the left ventricular outflow tract, vary in proportion to the injected alcohol volume in the 1-4 mL range.

🔬 Clinical Studies 34 words ▾

14 CLINICAL STUDIES Evidence of the effectiveness of ethanol on exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy was obtained from literature involving over 4000 patients.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ethanol (of alcohol beverages) was added to Group 1 International Agency for Research on Cancer (IARC) Carcinogenicity Ratings (IARC monographs). Substances in this group are either carcinogenic to humans, or there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the substance acts through a relevant mechanism of carcinogenicity. Alcohol consumption has been associated with various cancers, including liver, esophageal, breast, prostate, and colorectal cancer.

Since ABLYSINOL is not expected to reach the systemic circulation following administration into a septal artery during percutaneous transluminal septal myocardial ablation, the recommended clinical use of the drug product is not expected to have carcinogenic risk in patients. Literature reports suggest that ethanol is not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or in vitro chromosomal aberration assays. Ethanol is metabolized to acetaldehyde, which is a known mutagen.

There are no data from either animal or human studies regarding potential for the impairment of fertility.

13.2Animal Toxicology and/or Pharmacology The median lethal dose (LD 50 ) values for ethyl alcohol given by intravenous and oral routes are 1440 and 7060 mg/kg in rats and 1973 and 3450 mg/kg in mice, respectively. The LD 50 for ethyl alcohol given by subcutaneous injection is 8285 mg/kg in mice.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 166 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Ethanol (of alcohol beverages) was added to Group 1 International Agency for Research on Cancer (IARC) Carcinogenicity Ratings (IARC monographs). Substances in this group are either carcinogenic to humans, or there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the substance acts through a relevant mechanism of carcinogenicity. Alcohol consumption has been associated with various cancers, including liver, esophageal, breast, prostate, and colorectal cancer.

Since ABLYSINOL is not expected to reach the systemic circulation following administration into a septal artery during percutaneous transluminal septal myocardial ablation, the recommended clinical use of the drug product is not expected to have carcinogenic risk in patients. Literature reports suggest that ethanol is not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or in vitro chromosomal aberration assays. Ethanol is metabolized to acetaldehyde, which is a known mutagen.

There are no data from either animal or human studies regarding potential for the impairment of fertility.

📄 Package Label / Principal Display Panel 126 words ▾

PRINCIPAL DISPLAY PANEL - 1 mL AMPULE ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-105-01 1 mL - AMPULE - LABEL ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-105-10 1 mL - AMPULE - CARTON - 10 PACK 1 mL Label 1 mLCarton

PRINCIPAL DISPLAY PANEL - 5 mL AMPULE ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-105-02 5mL - AMPULE - LABEL ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-105-15 5mL - AMPULE - CARTON - 10 PACK 5mL ampul label 5 mL Ampule Carton

PRINCIPAL DISPLAY PANEL - 5 mL VIAL ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-144-01 5 mL - VIAL - LABEL ABLYSINOL® (Dehydrated Alcohol Injection, USP) NDC 54288-144-10 5 mL - VIAL - CARTON - 10 PACK 5 mL Vial Label 5 mL Vial Carton

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

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 BPI Labs, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BPI Labs, 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.
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.
← 54288-0142-10 · BPI 54288-0147-01 · BPI →
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.