NDC 0187-0010 Ammonul

Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0187-0010
Proprietary Name:
Ammonul
Non-Proprietary Name: [1]
Sodium Phenylacetate And Sodium Benzoate
Substance Name: [2]
Sodium Benzoate; Sodium Phenylacetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Bausch Health Us Llc
    Labeler Code:
    0187
    FDA Application Number: [6]
    NDA020645
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-17-2005
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0187-0010-50

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

    Product Details

    What is NDC 0187-0010?

    The NDC code 0187-0010 is assigned by the FDA to the product Ammonul which is a human prescription drug product labeled by Bausch Health Us Llc. The generic name of Ammonul is sodium phenylacetate and sodium benzoate. The product's dosage form is injection, solution, concentrate and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0187-0010-50 1 vial, single-use in 1 carton / 50 ml in 1 vial, single-use. 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 Ammonul?

    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)].

    What are Ammonul Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Ammonul UNII Codes?

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

    Which are Ammonul 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 Ammonul?

    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
    • 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]
    • RxCUI: 984120 - Ammonul (sodium benzoate 10 % / sodium phenylacetate 10 % ) in 50 ML Injection

    Which are the Pharmacologic Classes for Ammonul?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [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".