Ethamolin Injection, Solution
NDC Package 67871-479-06

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

Package Information

Ethamolin (ethanolamine oleate) injection is eTHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. This formulation utilizes a injection, solution delivery system. Marketed by Qol Medical, Llc., this product is identified by NDC 67871-479 and is authorized under FDA application NDA019357.

Identification & Billing

NDC Package Code
67871-479-06
Package Description
10 AMPULE in 1 BOX / 2 mL in 1 AMPULE
Product Code
67871-479
11-Digit Billing Format
67871047906
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ethamolin
Non-Proprietary Name
Ethanolamine Oleate
Substance Name
Ethanolamine Oleate
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ETHANOLAMINE OLEATE 50 mg/mL
Pharmacologic Class
Usage Information
ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding.Sclerotherapy with ETHAMOLIN has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.

Regulatory & Marketing

Labeler Name
Qol Medical, Llc.
Product Type
Human Prescription Drug
FDA Application #
NDA019357
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-22-1998
Listing Expiration
12-31-2026
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 67871-479-06 identifies a specific commercial package of 10 ampule in 1 box / 2 ml in 1 ampule of Ethamolin, a human prescription drug labeled by Qol Medical, Llc.. This injection, solution is formulated for intravenous use and contains ethanolamine oleate 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 Qol Medical, Llc. on December 22, 1998. The current certification is valid through December 31, 2026.

How is this Qol Medical, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67871047906. 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)
67871-479-06
11-Digit CMS (5-4-2)
67871-0479-06

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