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  4. NDC Product Code: 52268-101 Golytely

NDC 52268-101 Golytely

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52268-101?
  5. Golytely Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
52268-101
Proprietary Name:
Golytely
Product Type: [3]
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
End Marketing Date: [10]
10-31-2022
Listing Expiration Date: [11]
10-31-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Flavor(s):
PINEAPPLE (C73409 - PINEAPPLE)

Code Structure Chart

Product Details

What is NDC 52268-101?

The NDC code 52268-101 is assigned by the FDA to the product Golytely which is product labeled by Braintree Laboratories, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 52268-101-01 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.

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.

Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".