Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate
NDC Package 70511-101-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sodium Phenylacetate And Sodium Benzoate injection is  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. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Maia Pharmaceuticals, Inc, this product is identified by NDC 70511-101 and is authorized under FDA application ANDA208521.

Identification & Billing

NDC Package Code
70511-101-50
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code
70511-101
11-Digit Billing Format
70511010150
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

Clinical Specifications

Proprietary Name
Sodium Phenylacetate And Sodium Benzoate
Non-Proprietary Name
Sodium Phenylacetate And Sodium Benzoate
Substance Name
Sodium Benzoate; Sodium Phenylacetate
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Sodium phenylacetate and sodium benzoate injection 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
Maia Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA208521
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70511-101-50 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Sodium Phenylacetate And Sodium Benzoate, a human prescription drug labeled by Maia Pharmaceuticals, Inc. This injection, solution, concentrate is formulated for intravenous use and contains sodium benzoate; sodium phenylacetate 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 Maia Pharmaceuticals, Inc on May 22, 2017. The current certification is valid through December 31, 2026.

How is this Maia Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70511010150. 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)
70511-101-50
11-Digit CMS (5-4-2)
70511-0101-50

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