NDC 70556-100 Sodium Phenylacetate And Sodium Benzoate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
70556-100
Proprietary Name:
Sodium Phenylacetate And Sodium Benzoate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Ailex Pharmaceuticals, Llc
Labeler Code:
70556
Start Marketing Date: [9]
02-24-2016
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 70556-100-50

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE

Product Details

What is NDC 70556-100?

The NDC code 70556-100 is assigned by the FDA to the product Sodium Phenylacetate And Sodium Benzoate which is product labeled by Ailex Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70556-100-50 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sodium Phenylacetate And Sodium Benzoate?

Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% 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)].

Which are Sodium Phenylacetate And Sodium Benzoate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Sodium Phenylacetate And Sodium Benzoate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Sodium Phenylacetate And Sodium Benzoate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".