Ethacrynic Acid
NDC Package 52682-048-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ethacrynic Acid is a "water pill" (diuretic) that works in your kidneys to increase the amount of urine you make. Marketed by Ingenus Pharmaceuticals Nj, Llc, this product is identified by NDC 52682-048 and is authorized under FDA application ANDA205609.

Identification & Billing

NDC Package Code
52682-048-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
52682-048
11-Digit Billing Format
52682004801

Clinical Specifications

Proprietary Name
Ethacrynic Acid
Dosage Form
-
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
Ingenus Pharmaceuticals Nj, Llc
FDA Application #
ANDA205609
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-05-2016
End Marketing Date
07-05-2016
Listing Expiration
07-05-2016
Exclude Flag
D
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 52682-048-01 identifies a specific commercial package of 100 tablet in 1 bottle of Ethacrynic Acid, labeled by Ingenus Pharmaceuticals Nj, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ingenus Pharmaceuticals Nj, Llc on July 05, 2016. The current certification is valid through July 05, 2016.

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 Ingenus Pharmaceuticals Nj, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52682004801. 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)
52682-048-01
11-Digit CMS (5-4-2)
52682-0048-01

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