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NDC 68682-201 Peg-3350, Electrolytes, And Ascorbate

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68682-201?
  4. Peg-3350, Electrolytes, And Ascorbate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
68682-201
Proprietary Name:
Peg-3350, Electrolytes, And Ascorbate
Non-Proprietary Name: [1]
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, And Ascorbic Acid
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]
Oceanside Pharmaceuticals
Labeler Code:
68682
Product Label ID:
cd9c0751-10fa-4f5f-bf29-742823541d22
FDA Application Number: [6]
NDA021881
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-01-2006
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 68682-201-75

Package Description: 1 KIT in 1 CONTAINER * 1 L in 1 POUCH * 1 L in 1 POUCH

Price per Unit: $75.69556 per EA

Product Details

What is NDC 68682-201?

The NDC code 68682-201 is assigned by the FDA to the product Peg-3350, Electrolytes, And Ascorbate which is a human prescription drug product labeled by Oceanside Pharmaceuticals. The generic name of Peg-3350, Electrolytes, And Ascorbate is polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 68682-201-75 1 kit in 1 container * 1 l in 1 pouch * 1 l 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 Peg-3350, Electrolytes, And Ascorbate?

PEG-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Which are Peg-3350, Electrolytes, And Ascorbate UNII Codes?

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

Which are Peg-3350, Electrolytes, And Ascorbate 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 Peg-3350, Electrolytes, And Ascorbate?

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: 800915 - ascorbic acid 4.7 GM / polyethylene glycol 3350 100 GM / potassium chloride 1.015 GM / sodium ascorbate 5.9 GM / sodium chloride 2.69 GM / sodium sulfate 7.5 GM Powder for Oral Solution
  • RxCUI: 800915 - ascorbic acid 4700 MG / polyethylene glycol 3350 100000 MG / potassium chloride 1015 MG / sodium ascorbate 5900 MG / sodium chloride 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution
  • RxCUI: 800915 - vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution
  • RxCUI: 800915 - vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution
  • RxCUI: 800915 - vit-C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution

* Please review the disclaimer below.

Patient Education

Ascorbic Acid (Vitamin C)


Ascorbic acid (vitamin C) is used as a dietary supplement when the amount of ascorbic acid in the diet is not enough. People most at risk for ascorbic acid deficiency are those with a limited variety of food in their diet, or who have intestinal malabsorption problems from cancer or kidney disease. Ascorbic acid is also used to prevent and treat scurvy (a disease that causes fatigue, gum swelling, joint pain, and poor wound healing from a lack of vitamin C in the body). Ascorbic acid is in a class of medications called antioxidants. It is needed by the body to help wounds heal, to enhance the absorption of iron from plant foods, and to support the immune system. It works as an antioxidant to protect your cells against free radicals, which may play a role in heart disease, cancer and other diseases.
[Learn More]


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".