Ethyol Injection
NDC Package 83107-030-02

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

Package Information

Ethyol (amifostine) injection is amifostine is used to decrease the risk of kidney problems caused by treatment with a certain anti-cancer drug (cisplatin). This formulation utilizes a injection delivery system. Marketed by Legacy Pharma Usa Inc., this product is identified by NDC 83107-030 and is authorized under FDA application NDA020221.

Identification & Billing

NDC Package Code
83107-030-02
Package Description
3 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01)
Product Code
83107-030
11-Digit Billing Format
83107003002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ethyol
Non-Proprietary Name
Amifostine
Substance Name
Amifostine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AMIFOSTINE 500 mg/10mL
Pharmacologic Class
Usage Information
Amifostine is used to decrease the risk of kidney problems caused by treatment with a certain anti-cancer drug (cisplatin). It is also used to help prevent a certain side effect (dry mouth) caused by radiation treatment for head and neck cancer. Amifostine is thought to work by preventing certain chemicals from damaging healthy cells. It may also help repair cells damaged by cisplatin or radiation treatment.

Regulatory & Marketing

Labeler Name
Legacy Pharma Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020221
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-16-2026
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 83107-030-02 identifies a specific commercial package of 3 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (83107-030-01) of Ethyol, a human prescription drug labeled by Legacy Pharma Usa Inc.. This injection is formulated for intravenous use and contains amifostine 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 Legacy Pharma Usa Inc. on March 16, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Amifostine is used to decrease the risk of kidney problems caused by treatment with a certain anti-cancer drug (cisplatin). It is also used to help prevent a certain side effect (dry mouth) caused by radiation treatment for head and neck cancer. Amifostine is thought to work by preventing certain chemicals from damaging healthy cells. It may also help repair cells damaged by cisplatin or radiation treatment.

How is this Legacy Pharma Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107003002. 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)
83107-030-02
11-Digit CMS (5-4-2)
83107-0030-02

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