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  5. NDC Package Code: 69784-811-01 Sodium Phenylacetate And Sodium Benzoate

NDC Package 69784-811-01 Sodium Phenylacetate And Sodium Benzoate

Injection, Solution, Concentrate 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:
69784-811-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code:
69784-811
Proprietary Name:
Sodium Phenylacetate And Sodium Benzoate
Non-Proprietary Name:
Sodium Phenylacetate And Sodium Benzoate
Substance Name:
Sodium Benzoate; Sodium Phenylacetate
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:
69784081101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Woodward Pharma Services Llc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SODIUM BENZOATE 100 mg/mL
  • SODIUM PHENYLACETATE 100 mg/mL
    • Pharmacologic Class(es):
  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207096
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-15-2021
    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 69784-811-01?

    The NDC Packaged Code 69784-811-01 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, a human prescription drug labeled by Woodward Pharma Services Llc. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 69784-811 included in the NDC Directory?

    Yes, Sodium Phenylacetate And Sodium Benzoate with product code 69784-811 is active and included in the NDC Directory. The product was first marketed by Woodward Pharma Services Llc on December 15, 2021 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 NDC billing unit for package 69784-811-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 69784-811-01?

    The 11-digit format is 69784081101. 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
    5-3-269784-811-015-4-269784-0811-01