Plenvu Kit
NDC Package 65649-400-01

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

Package Information

Plenvu (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate) kits is pEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy. This formulation utilizes a kit delivery system. Marketed by Salix Pharmaceuticals, Inc, this product is identified by NDC 65649-400 and is authorized under FDA application NDA209381.

Identification & Billing

NDC Package Code
65649-400-01
Package Description
1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH
Product Code
65649-400
11-Digit Billing Format
65649040001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 2045233 - polyethylene glycol 3350 100 GM / potassium chloride 1 GM / sodium chloride 2 GM / sodium sulfate 9 GM Powder for Oral Solution
  • RxCUI: 2045233 - polyethylene glycol 3350 100000 MG / potassium chloride 1000 MG / sodium chloride 2000 MG / sodium sulfate 9000 MG Powder for Oral Solution
  • RxCUI: 2045233 - POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1000 MG / NaCl 2000 MG / sodium sulfate 9000 MG Powder for Oral Solution
  • RxCUI: 2045233 - POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1000 MG / NaCl 2000 MG / sodium sulfate 9000 MG Powder for Oral Solution
  • RxCUI: 2045243 - ascorbic acid 7540 MG / polyethylene glycol 3350 40000 MG / potassium chloride 1200 MG / sodium ascorbate 48110 MG / sodium chloride 3200 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Plenvu
Non-Proprietary Name
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy. It is a laxative that works by drawing large amounts of water into the colon. This 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
Salix Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA209381
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-04-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65649-400). Click a package code to view its specific billing and regulatory data.

65649-400-02
1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH

* 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 65649-400-01 identifies a specific commercial package of 1 kit in 1 carton * 46.26 powder, for solution in 1 pouch * 55.65 powder, for solution in 1 pouch * 115.96 powder, for solution in 1 pouch of Plenvu, a human prescription drug labeled by Salix Pharmaceuticals, Inc. This kit is formulated for use and contains 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 Salix Pharmaceuticals, Inc on May 04, 2018. 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. It is a laxative that works by drawing large amounts of water into the colon. This results in watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

How is this Salix Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65649040001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
65649-400-01
11-Digit CMS (5-4-2)
65649-0400-01

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