1. Home
  2. Labeler Index
  3. Braintree Laboratories, Inc.
  4. NDC Product Code: 52268-100 Golytely

NDC 52268-100 Golytely

Polyethylene Glycol 3350,Sodium Sulfate Anhydrous,Sodium Bicarbonate,Sodium - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 52268-100?
  4. Golytely Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes
  9. Patient Education

Product Information

NDC Product Code:
52268-100
Proprietary Name:
Golytely
Non-Proprietary Name: [1]
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Substance Name: [2]
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous
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]
    Braintree Laboratories, Inc.
    Labeler Code:
    52268
    Product Label ID:
    57d22b0b-1ae0-4203-babc-f3bac17bd1c9
    FDA Application Number: [6]
    NDA019011
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-13-1984
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 52268-100?

    The NDC code 52268-100 is assigned by the FDA to the product Golytely which is a human prescription drug product labeled by Braintree Laboratories, Inc.. The generic name of Golytely is polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, 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 52268-100-01 4 l 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 Golytely?

    PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy or barium enema X-rays. It is a laxative that works by drawing large amounts of water into the colon. This effect results in watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

    What are Golytely 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 Golytely UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Golytely?

    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: 1870431 - polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM Powder for Oral Solution
    • RxCUI: 1870431 - polyethylene glycol 3350 227100 MG / potassium chloride 2820 MG / sodium bicarbonate 6360 MG / sodium chloride 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution
    • RxCUI: 1870431 - POLYETHYLENE GLYCOL 3350 227100 MG / K+ Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution
    • RxCUI: 1870431 - POLYETHYLENE GLYCOL 3350 227100 MG / Pot Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution
    • RxCUI: 966916 - GoLYTELY Packet Powder for Oral Solution

    * 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".