Gavilyte-n Powder, For Solution
NDC Package 43386-050-19

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

Package Information

Gavilyte-n (polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate) 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 Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-050 and is authorized under FDA application ANDA090019.

Identification & Billing

NDC Package Code
43386-050-19
Package Description
438.4 g in 1 BOTTLE
Product Code
43386-050
11-Digit Billing Format
43386005019
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Gavilyte-n
Non-Proprietary Name
Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
Substance Name
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride
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
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090019
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 43386-050-19 identifies a specific commercial package of 438.4 g in 1 bottle of Gavilyte-n, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride 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 Lupin Pharmaceuticals,inc. on May 28, 2009. 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 Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386005019. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
43386-050-19
11-Digit CMS (5-4-2)
43386-0050-19

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