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DEHYDRATED ALCOHOL 1 mL/mL Injection, Solution — NDC 16729-0710-45 package photo

DEHYDRATED ALCOHOL 1 mL/mL Injection, Solution

by Accord Healthcare, Inc. · 10 VIAL in 1 CARTON (16729-710-45) / 5 mL in 1 VIAL (16729-710-31)
NDC 16729-0710-45
🏷️ FDA NDC (as labeled) 16729-710-45 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial Medicaid pays$166.55 / unit · 12 mo Per package$8,327.53 / 50 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 5 vials 16729-0710-53
Rx only Generic On market Non-controlled ⚠ On shortage
🗂️ 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 →

This page is curated, coded, and maintained by

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

⚠️
Active FDA shortage. Dehydrated Alcohol Injection, Solution is currently reported in shortage by the FDA. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 16729-710-45
Product NDC 16729-710
11-digit billing NDC 16729071045
NCPDP billing unit ML — per mL (volume)
RxCUI 2048982
UNII 3K9958V90M
Application # ANDA217845
SPL Set ID 07fa92f7-d752-42e3-a572-b552461c4389
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-25
Route PERCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ALCOHOL
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 DEHYDRATED ALCOHOL 99% VIAL
FDB brand name Dehydrated Alcohol
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 16729-710-45 — 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 → 16729-0710-45. 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.

🏭 Manufacturer & labeler

LabelerAccord Healthcare, Inc.
Application holderACCORD HEALTHCARE INC
FDA applicationANDA217845 (ANDA)
Labeler code16729
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio67 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 DEHYDRATED ALCOHOL 99% VIAL Ingredient Ethyl Alcohol
📗 Our plain-language guide HelloPharmacist
  • Chemically they are related, but hand sanitizer is absolutely not safe to drink — it contains alcohol in concentrations that are toxic if swallowed and often includes other ingredi...
  • Is the alcohol in hand sanitizer the same as the alcohol in a drink?
  • Yes — most of these products are specifically labeled 'recommended for repeated use.' Just apply enough to cover your hands and rub until dry. If you notice skin irritation or redn...
  • Can I use hand sanitizer over and over throughout the day?
📖 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.

🧪 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.

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.

💲 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 $166.55 $8,327.53 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
Dehydrated Alcohol 1 mL/mLthis 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 — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 54288-0144-10 BPI 10 vials — AP 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 — AP FDA listed —
Dehydrated Alcohol 1 mL/mL 83634-0306-05 Avenacy, 5 vials — AP FDA listed —
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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 16729-0710-45, 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.
📅 Q3 2025 – Q4 2025 · 2 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
67
Units reimbursed last 4 qtrs
239
Gross reimbursed last 4 qtrs
$39.8K
Avg / prescription
$594.11
Avg / unit
$166.55
Latest quarter Q4 2025
43Rx
Fee-for-service vs managed care ⓘ
21% FFS 79% MCO
Fee-for-service · 14 Rx Managed care · 53 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported 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: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported 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: 90 units · 0.7 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 24 units · 0.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 125 units · 3.1 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.23.1
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 Oklahoma 3.1 /100k
2 Illinois 0.7 /100k
3 Pennsylvania 0.2 /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.
10 vials this page16729-0710-45 67 Rx · $39,806
5 vials16729-0710-53 No Medicaid data
Drug total (last 4 qtrs): 67 Rx · 239 units · $39,806 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
16729-0710-45 You're viewing this 10 VIAL in 1 CARTON (16729-710-45) / 5 mL in 1 VIAL (16729-710-31) 2025-06-25 Active
16729-0710-53 5 VIAL in 1 CARTON (16729-710-53) / 5 mL in 1 VIAL (16729-710-31) 2026-04-16 Active

Pack size FAQ

What quantity is in NDC 16729-0710-45?
NDC 16729-0710-45 is listed by the FDA — 10 vial in 1 carton / 5 ml in 1 vial.
What NDC number is used to bill for this package of DEHYDRATED ALCOHOL 1 mL/mL Injection, Solution?
Bill NDC 16729-0710-45 — the 11-digit billing format is 16729071045. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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 ✓ Available
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) ✓ Available
“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 FDA registers it as 16729-710-45, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 16729-0710-45, written without dashes as 16729071045. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 16729-0710-45, the first segment (16729) is the labeler code FDA assigned to Accord Healthcare, Inc.; the middle segment (0710) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Accord Healthcare, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 vials (16729-0710-53). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Accord Healthcare, Inc. 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.

📄 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
🎯 Indications and Usage 66 words ▾

1 INDICATIONS & USAGE Dehydrated 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. (1)

⏱️ Dosage and Administration 186 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 dehydrated alcohol injection that should be used in a single procedure is 5 mL.

2.2Administration Dehydrated alcohol injection 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. Dehydrated alcohol injection should appear as a clear, colorless solution. Discard unused portion.

💊 Dosage Forms and Strengths 46 words ▾

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

⛔ Contraindications 5 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 dehydrated alcohol injection, 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, 3rd degree atrio-ventricular block occurring during the procedure, and no clinical recovery between 12 to 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 dehydrated alcohol injection, 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 Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS • Dehydrated alcohol injection 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)

8.1Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but dehydrated alcohol injection 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 Dehydrated alcohol injection 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 Dehydrated alcohol injection 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 147 words ▾

8.1Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but dehydrated alcohol injection 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 Dehydrated alcohol injection 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 168 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 to 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 to 4 mL range.

12.3Pharmacokinetics Because injection of dehydrated alcohol 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 112 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dehydrated alcohol injection, USP is a clear, colorless liquid supplied in clear, glass, single-dose vials. Each mL contains ≥ 99% by volume ethyl alcohol. NDC Number Package Size 16729-710-53 5 x 5 mL Single-Dose Vials 16729-710-45 10 x 5 mL Single-Dose Vials 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. Manufactured for: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.

Manufactured By: Maiva Pharma Private Limited Plot No 32, Sipcot Industrial Complex, Phase-I, Hosur, Tamil Nadu, India 635126. Product of Republic of Ireland. Issued July 2025

📋 Description 78 words ▾

11 DESCRIPTION Dehydrated alcohol injection, USP is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP 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: Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16729-0697-06 · Accord 16729-0723-51 · Accord →
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.