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  4. NDC Product Code: 10572-012 Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

NDC 10572-012 Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Sodium Sulfate,Potassium Sulfate,Magnesium Sulfate Solution, Concentrate Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10572-012?
  5. Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
10572-012
Proprietary Name:
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Non-Proprietary Name: [1]
Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate
Substance Name: [2]
Magnesium Sulfate, Unspecified Form; Potassium Sulfate; Sodium Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Affordable Pharmaceuticals, Llc
    Labeler Code:
    10572
    Product Label ID:
    f86bdcc8-e643-4160-89ae-01c89bee842d
    FDA Application Number: [6]
    NDA022372
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-05-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    BERRY (C73365 - BERRY)

    Code Structure Chart

    Product Details

    What is NDC 10572-012?

    The NDC code 10572-012 is assigned by the FDA to the product Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate which is a human prescription drug product labeled by Affordable Pharmaceuticals, Llc. The generic name of Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate is sodium sulfate, potassium sulfate, magnesium sulfate. The product's dosage form is solution, concentrate and is administered via oral form. The product is distributed in a single package with assigned NDC code 10572-012-01 2 bottle, plastic in 1 carton / 177.4 ml in 1 bottle, plastic. 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 Sulfate, Potassium Sulfate And Magnesium Sulfate?

    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.

    What are Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 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 Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate UNII Codes?

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

    Which are Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 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 Sulfate, Potassium Sulfate And Magnesium Sulfate?

    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: 1001689 - {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack
    • RxCUI: 1001689 - 2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack
    • RxCUI: 1120068 - magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral Solution
    • RxCUI: 1120068 - magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution
    • RxCUI: 1120068 - Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution

    Which are the Pharmacologic Classes for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate?

    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.

    Patient Education

    Magnesium Sulfate, Potassium Sulfate, and Sodium Sulfate


    Magnesium sulfate, potassium sulfate, and sodium sulfate is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) in adults and children 12 years of age and older so that the doctor will have a clear view of the walls of the colon. Magnesium sulfate, potassium sulfate, and sodium sulfate is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon.
    [Learn More]


    Sodium Phosphate


    Sodium phosphate is used in adults 18 years of age or older to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) so that the doctor will have a clear view of the walls of the colon. Sodium phosphate is in a class of medications called saline laxatives. It works by causing diarrhea so that the stool can be emptied from the colon.
    [Learn More]


    * 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".