NDC Package 70556-100-50 Sodium Phenylacetate And Sodium Benzoate

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
70556-100-50
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Sodium Phenylacetate And Sodium Benzoate
Usage Information:
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)].
11-Digit NDC Billing Format:
70556010050
NDC to 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
  • Labeler Name:
    Ailex Pharmaceuticals, Llc
    Sample Package:
    No
    Start Marketing Date:
    02-24-2016
    Listing Expiration Date:
    12-31-2021
    Exclude Flag:
    I
    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 70556-100-50?

    The NDC Packaged Code 70556-100-50 is assigned to a package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Sodium Phenylacetate And Sodium Benzoate, labeled by Ailex Pharmaceuticals, Llc. The product's dosage form is and is administered via form.

    Is NDC 70556-100 included in the NDC Directory?

    No, Sodium Phenylacetate And Sodium Benzoate with product code 70556-100 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Ailex Pharmaceuticals, Llc on February 24, 2016 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70556-100-50?

    The 11-digit format is 70556010050. 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
    5-3-270556-100-505-4-270556-0100-50