Dehydrated Alcohol Injection, Solution
NDC Package 83634-306-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dehydrated Alcohol (alcohol) injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Avenacy, Llc, this product is identified by NDC 83634-306 and is authorized under FDA application ANDA219569.

Identification & Billing

NDC Package Code
83634-306-05
Package Description
5 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (83634-306-41)
Product Code
83634-306
11-Digit Billing Format
83634030605
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dehydrated Alcohol
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Percutaneous - Administration through the skin.
Active Ingredient(s)
ALCOHOL 1 mL/mL
Usage Information
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.

Regulatory & Marketing

Labeler Name
Avenacy, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219569
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-17-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83634-306-05 identifies a specific commercial package of 5 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (83634-306-41) of Dehydrated Alcohol, a human prescription drug labeled by Avenacy, Llc. This injection, solution is formulated for percutaneous use and contains alcohol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avenacy, Llc on July 17, 2025. The current certification is valid through December 31, 2027.

How is this Avenacy, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83634030605. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83634-306-05
11-Digit CMS (5-4-2)
83634-0306-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.