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NDC 65649-400 Plenvu

Polyethylene Glycol 3350,Sodium Sulfate,Sodium Chloride,Potassium Chloride,Ascorbic - View Dosage, Usage, Ingredients, Routes, UNII

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

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
Dosage Form:
Kit - A packaged collection of related material.
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.
Start Marketing Date: [9]
05-04-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 65649-400?

The NDC code 65649-400 is assigned by the FDA to the product Plenvu which is a human prescription drug product labeled by Salix Pharmaceuticals, Inc. The generic name of Plenvu is polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 65649-400-01 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, 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. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Plenvu?

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 Plenvu UNII Codes?

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

Which are Plenvu Inactive Ingredients 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 Plenvu?

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 disclaimer below.

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.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".