Ethacrynic Acid Powder
NDC Package 48581-320-22

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ethacrynic Acid powders is ethacrynic acid is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. This formulation utilizes a powder delivery system. Marketed by Egis Pharmaceuticals Plc, this product is identified by NDC 48581-320.

Identification & Billing

NDC Package Code
48581-320-22
Package Description
1 BAG in 1 DRUM / 10 kg in 1 BAG
Product Code
48581-320
11-Digit Billing Format
48581032022

Clinical Specifications

Proprietary Name
Ethacrynic Acid
Non-Proprietary Name
Ethacrynic Acid
Substance Name
Ethacrynic Acid
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ETHACRYNIC ACID 1 kg/kg
Usage Information
Ethacrynic acid is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. This helps your body get rid of extra water. This medication is used to decrease swelling (edema) caused by conditions such as cancer, congestive heart failure, liver disease, and kidney disease. This effect can help your kidneys work better and lessen symptoms such as trouble breathing and swelling in your ankles, feet, hands, or belly. This medication should not be used for infants.

Regulatory & Marketing

Labeler Name
Egis Pharmaceuticals Plc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
04-15-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (48581-320). Click a package code to view its specific billing and regulatory data.

48581-320-20
1 BAG in 1 DRUM / 1 kg in 1 BAG
48581-320-21
1 BAG in 1 DRUM / 5 kg in 1 BAG
48581-320-23
1 BAG in 1 DRUM / 20 kg in 1 BAG
48581-320-24
1 BAG in 1 DRUM / 25 kg in 1 BAG
48581-320-26
1 BAG in 1 DRUM / 15 kg in 1 BAG
48581-320-27
1 BAG in 1 DRUM / 2 kg in 1 BAG

* 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 48581-320-22 identifies a specific commercial package of 1 bag in 1 drum / 10 kg in 1 bag of Ethacrynic Acid (UNFINISHED drug), a bulk ingredient labeled by Egis Pharmaceuticals Plc. This powder is formulated for use and contains ethacrynic acid 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 Egis Pharmaceuticals Plc on April 15, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ethacrynic acid is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. This helps your body get rid of extra water. This medication is used to decrease swelling (edema) caused by conditions such as cancer, congestive heart failure, liver disease, and kidney disease. This effect can help your kidneys work better and lessen symptoms such as trouble breathing and swelling in your ankles, feet, hands, or belly. This medication should not be used for infants.

How is this Egis Pharmaceuticals Plc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48581032022. 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)
48581-320-22
11-Digit CMS (5-4-2)
48581-0320-22

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