Plenvu Kit
NDC 65649-400

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 65649-400?
  4. Plenvu Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Plenvu (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate) is a NDA-approved product labeled by Salix Pharmaceuticals, Inc. PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy. It is supplied as a kit. This product entry covers the primary NDC 65649-400 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65649-400
Proprietary Name:
Plenvu
Non-Proprietary Name: [1]
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Salix Pharmaceuticals, Inc
Labeler Code:
65649
Product Label ID:
79f930fa-5674-4f30-8ae8-9448d6243797
FDA Application Number: [6]
NDA209381
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-04-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 65649-400?

The NDC code 65649-400 is assigned by the FDA to the product Plenvu. It is commonly known by its generic name, polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate. This pharmaceutical product is labeled by Salix Pharmaceuticals, Inc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 65649-400-01, 65649-400-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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: 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

* Please review the full disclaimer at the bottom of this page.

Patient Education

Polyethylene glycol-electrolyte solution (PEG-ES)


Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon. The medication also contains electrolytes to prevent dehydration and other serious side effects that may be caused by fluid loss as the colon is emptied.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".