Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
NDC Package 40032-050-19

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate is pEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-050 and is authorized under FDA application ANDA090019.

Identification & Billing

NDC Package Code
40032-050-19
Package Description
438.4 g in 1 BOTTLE
Product Code
40032-050
11-Digit Billing Format
40032005019
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
Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
Dosage Form
-
Usage Information
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy.

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
FDA Application #
ANDA090019
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 40032-050-19 identifies a specific commercial package of 438.4 g in 1 bottle of Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate, labeled by Novel Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novel Laboratories, Inc. on May 28, 2009. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032005019. 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)
40032-050-19
11-Digit CMS (5-4-2)
40032-0050-19

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