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  4. NDC Product Code: 10572-302 Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride

NDC 10572-302 Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride

Polyethylene Glycol 3350,Sodium Chloride,Sodium Bicarbonate,Potassium Chloride Powder, For - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10572-302?
  5. Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
10572-302
Proprietary Name:
Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride
Non-Proprietary Name: [1]
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride
Substance Name: [2]
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
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:
    89ca6d56-527a-4be2-baea-531156f0a7be
    FDA Application Number: [6]
    NDA019797
    Marketing Category: [8]
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date: [9]
    02-08-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    LEMON (C73396 - LEMON)
    LIME (C73398 - LIME)

    Code Structure Chart

    Product Details

    What is NDC 10572-302?

    The NDC code 10572-302 is assigned by the FDA to the product Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride which is a human prescription drug product labeled by Affordable Pharmaceuticals, Llc. The generic name of Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride is polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride. The product's dosage form is powder, for solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 10572-302-01 4 l in 1 bottle . 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 Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride?

    PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

    What are Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride 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 Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride?

    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: 801054 - PEG-3350 420 GM / sodium chloride 11.2 GM / sodium bicarbonate 5.72 GM / potassium chloride 1.48 GM Powder for Oral Solution
    • RxCUI: 801054 - polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution
    • RxCUI: 801054 - PEG 3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM per 4 L Powder for Oral Solution
    • RxCUI: 801054 - PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution
    • RxCUI: 801054 - POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution

    Which are the Pharmacologic Classes for Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride?

    * Please review the disclaimer below.

    Patient Education

    Polyethylene glycol-electrolyte solution (PEG-ES)


    Polyethylene glycol-electrolyte solution (PEG-ES) 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) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES 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. The medication also contains electrolytes to prevent dehydration and other serious side effects that may be caused by fluid loss as the colon is emptied.
    [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".