Ammonul
NDC Package 62592-720-50

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 inactivated by the FDA.

Ammonul is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. Marketed by Ucyclyd Pharma Inc., this product is identified by NDC 62592-720 and is authorized under FDA application NDA020645.

Identification & Billing

NDC Package Code
62592-720-50
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE
Product Code
62592-720
11-Digit Billing Format
62592072050
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 984118 - sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML Injection
  • RxCUI: 984118 - 50 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection
  • RxCUI: 984118 - sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML Injection
  • RxCUI: 984120 - AMMONUL 10 % / 10 % in 50 ML Injection
  • RxCUI: 984120 - 50 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection [Ammonul]

Clinical Specifications

Proprietary Name
Ammonul
Dosage Form
-
Usage Information
AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [ see Warnings and Precautions (5)].

Regulatory & Marketing

Labeler Name
Ucyclyd Pharma Inc.
FDA Application #
NDA020645
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-17-2005
Listing Expiration
12-31-2019
Exclude Flag
I
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 62592-720-50 identifies a specific commercial package of 1 vial, single-use in 1 carton / 50 ml in 1 vial, single-use of Ammonul, labeled by Ucyclyd Pharma Inc.. 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 Ucyclyd Pharma Inc. on February 17, 2005. The current certification is valid through December 31, 2019.

How is this Ucyclyd Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62592072050. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
62592-720-50
11-Digit CMS (5-4-2)
62592-0720-50

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