Golytely Powder, For Solution
NDC Package 52268-100-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Golytely (polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride) powders is 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. This formulation utilizes a powder, for solution delivery system. Marketed by Braintree Laboratories, Inc., this product is identified by NDC 52268-100 and is authorized under FDA application NDA019011.

Identification & Billing

NDC Package Code
52268-100-01
Package Description
4 L in 1 BOTTLE, PLASTIC
Product Code
52268-100
11-Digit Billing Format
52268010001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
4000 ML
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Golytely
Non-Proprietary Name
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Substance Name
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Braintree Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019011
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-13-1984
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52268-100-01 identifies a specific commercial package of 4 l in 1 bottle, plastic of Golytely, a human prescription drug labeled by Braintree Laboratories, Inc.. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Braintree Laboratories, Inc. on July 13, 1984. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Braintree Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52268010001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 4000 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52268-100-01
11-Digit CMS (5-4-2)
52268-0100-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.