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  4. NDC Product Code: 65219-387 Multiple Electrolytes Ph 5.5

NDC 65219-387 Multiple Electrolytes Ph 5.5

Sodium Chloride,Sodium Gluconate,Sodium Acetate,Potassium Chloride And Magnesium Chloride - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 65219-387?
  4. Multiple Electrolytes Ph 5.5 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
65219-387
Proprietary Name:
Multiple Electrolytes Ph 5.5
Non-Proprietary Name: [1]
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride
Substance Name: [2]
Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Fresenius Kabi Usa, Llc
    Labeler Code:
    65219
    Product Label ID:
    cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c
    FDA Application Number: [6]
    ANDA215370
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 65219-387-05

    Package Description: 20 BAG in 1 CASE / 500 mL in 1 BAG (65219-387-00)

    NDC Code 65219-387-10

    Package Description: 10 BAG in 1 CASE / 1000 mL in 1 BAG (65219-387-02)

    Product Details

    What is NDC 65219-387?

    The NDC code 65219-387 is assigned by the FDA to the product Multiple Electrolytes Ph 5.5 which is a human prescription drug product labeled by Fresenius Kabi Usa, Llc. The generic name of Multiple Electrolytes Ph 5.5 is sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 65219-387-05 20 bag in 1 case / 500 ml in 1 bag (65219-387-00), 65219-387-10 10 bag in 1 case / 1000 ml in 1 bag (65219-387-02). 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 Multiple Electrolytes Ph 5.5?

    Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.

    What are Multiple Electrolytes Ph 5.5 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.
    • MAGNESIUM CHLORIDE 30 mg/100mL - Magnesium chloride. An inorganic compound consisting of one magnesium and two chloride ions. The compound is used in medicine as a source of magnesium ions, which are essential for many cellular activities. It has also been used as a cathartic and in alloys.
    • POTASSIUM CHLORIDE 37 mg/100mL - A white crystal or crystalline powder used in BUFFERS; FERTILIZERS; and EXPLOSIVES. It can be used to replenish ELECTROLYTES and restore WATER-ELECTROLYTE BALANCE in treating HYPOKALEMIA.
    • SODIUM ACETATE 368 mg/100mL - The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.
    • SODIUM CHLORIDE 526 mg/100mL - A ubiquitous sodium salt that is commonly used to season food.
    • SODIUM GLUCONATE 502 mg/100mL

    Which are Multiple Electrolytes Ph 5.5 UNII Codes?

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

    Which are Multiple Electrolytes Ph 5.5 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 Multiple Electrolytes Ph 5.5?

    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: 801109 - magnesium chloride 0.00148 MEQ/mL / potassium chloride 0.00497 MEQ/mL / sodium acetate 0.027 MEQ/mL / sodium chloride 0.0899 MEQ/mL / sodium gluconate 5.02 MG/mL Injectable Solution
    • RxCUI: 801109 - magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.00497 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution
    • RxCUI: 801109 - Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution
    • RxCUI: 801109 - Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.00497 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution

    Which are the Pharmacologic Classes for Multiple Electrolytes Ph 5.5?

    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".