Ethacrynate Sodium Injection, Powder, For Solution
NDC Package 42023-157-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Ethacrynate Sodium injection is ethacrynate sodium 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. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 42023-157 and is authorized under FDA application ANDA205473.

Identification & Billing

NDC Package Code
42023-157-99
Package Description
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
11-Digit Billing Format
42023015799
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 617325 - ethacrynate sodium 50 MG Injection
  • RxCUI: 617325 - ethacrynate sodium 50 MG (equivalent to ethacrynic acid 50 MG) Injection

Clinical Specifications

Proprietary Name
Ethacrynate Sodium
Non-Proprietary Name
Ethacrynate Sodium
Substance Name
Ethacrynate Sodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Usage Information
Ethacrynate sodium 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
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA205473
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-30-2015
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 (42023-157). Click a package code to view its specific billing and regulatory data.

1 VIAL in 1 CARTON / 50 mL in 1 VIAL
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 42023-157-99 identifies a specific commercial package of 1 vial in 1 carton / 50 ml in 1 vial of Ethacrynate Sodium, a human prescription drug labeled by Par Health Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for intravenous use and contains ethacrynate sodium 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 Par Health Usa, Llc on July 30, 2015. The current certification is valid through December 31, 2026.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023015799. 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)
42023-157-99
11-Digit CMS (5-4-2)
42023-0157-99

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