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  5. NDC Package Code: 43386-050-19 Gavilyte-n

NDC Package 43386-050-19 Gavilyte-n

Polyethylene Glycol-3350,Sodium Chloride,Potassium Chloride And Sodium Bicarbonate Powder, - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43386-050-19
Package Description:
438.4 g in 1 BOTTLE
Product Code:
43386-050
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
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.
11-Digit NDC Billing Format:
43386005019
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • POLYETHYLENE GLYCOL 3350 420 g/438.4g
  • POTASSIUM CHLORIDE 1.48 g/438.4g
  • SODIUM BICARBONATE 5.72 g/438.4g
  • SODIUM CHLORIDE 11.2 g/438.4g
    • Pharmacologic Class(es):
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090019
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-28-2009
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 43386-050-19?

    The NDC Packaged Code 43386-050-19 is assigned to a package of 438.4 g in 1 bottle of Gavilyte-n, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is powder, for solution and is administered via oral form.

    Is NDC 43386-050 included in the NDC Directory?

    Yes, Gavilyte-n with product code 43386-050 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on May 28, 2009 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43386-050-19?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 43386-050-19?

    The 11-digit format is 43386005019. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243386-050-195-4-243386-0050-19