Ethacrynic Sodium
NDC Package 68682-012-50

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

Ethacrynic Sodium is ethacrynic acid is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-012 and is authorized under FDA application NDA016093.

Identification & Billing

NDC Package Code
68682-012-50
Package Description
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
68682-012
11-Digit Billing Format
68682001250
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ethacrynic Sodium
Dosage Form
-
Usage Information
Ethacrynic acid is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4.Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
FDA Application #
NDA016093
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-10-1967
End Marketing Date
09-30-2023
Listing Expiration
09-30-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68682-012). Click a package code to view its specific billing and regulatory data.

68682-012-27
1 VIAL in 1 CARTON / 50 mL in 1 VIAL

* 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 68682-012-50 identifies a specific commercial package of 1 vial in 1 carton / 50 ml in 1 vial of Ethacrynic Sodium, labeled by Oceanside Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Oceanside Pharmaceuticals on January 10, 1967. The current certification is valid through September 30, 2023.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682001250. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
68682-012-50
11-Digit CMS (5-4-2)
68682-0012-50

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