Ethacrynic Acid Tablet
NDC Package 52817-367-10

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

Ethacrynic Acid tablets 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 tablet delivery system. Marketed by Trupharma Llc, this product is identified by NDC 52817-367 and is authorized under FDA application ANDA211809.

Identification & Billing

NDC Package Code
52817-367-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
52817-367
11-Digit Billing Format
52817036710
RxNorm Crosswalk
RxCUI: 1251903 - ethacrynic acid 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ethacrynic Acid
Non-Proprietary Name
Ethacrynic Acid
Substance Name
Ethacrynic Acid
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ETHACRYNIC ACID 25 mg/1
Pharmacologic Class
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
Trupharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211809
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-12-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52817-367). Click a package code to view its specific billing and regulatory data.

52817-367-90
90 TABLET in 1 BOTTLE

* 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 52817-367-10 identifies a specific commercial package of 100 tablet in 1 bottle of Ethacrynic Acid, a human prescription drug labeled by Trupharma Llc. This tablet is formulated for oral 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 Trupharma Llc on September 12, 2019. 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 Trupharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817036710. 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)
52817-367-10
11-Digit CMS (5-4-2)
52817-0367-10

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