1. Home
  2. Labeler Index
  3. Leading Pharma, Llc
  4. 69315-701
  5. NDC Package Code: 69315-701-50 Ethacrynate Sodium

NDC Package 69315-701-50 Ethacrynate Sodium

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69315-701-50
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code:
69315-701
Proprietary Name:
Ethacrynate Sodium
Non-Proprietary Name:
Ethacrynate Sodium
Substance Name:
Ethacrynate Sodium
Usage Information:
Ethacryname Sodium is indicated for treatment of edema when as agent with greater diuretic potential than those commonly employed is required.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.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.
11-Digit NDC Billing Format:
69315070150
NDC to RxNorm Crosswalk:
  • RxCUI: 617325 - ethacrynate sodium 50 MG Injection
  • RxCUI: 617325 - ethacrynate sodium 50 MG (equivalent to ethacrynic acid 50 MG) Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leading Pharma, Llc
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ETHACRYNATE SODIUM 50 mg/50mL
    • Pharmacologic Class(es):
  • Increased Diuresis at Loop of Henle - [PE] (Physiologic Effect)
  • Loop Diuretic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208663
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-15-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69315-701-50?

    The NDC Packaged Code 69315-701-50 is assigned to a package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Ethacrynate Sodium, a human prescription drug labeled by Leading Pharma, Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 69315-701 included in the NDC Directory?

    Yes, Ethacrynate Sodium with product code 69315-701 is active and included in the NDC Directory. The product was first marketed by Leading Pharma, Llc on October 15, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69315-701-50?

    The 11-digit format is 69315070150. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269315-701-505-4-269315-0701-50