Gavilyte - C Powder, For Solution
NDC 43386-060

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43386-060?
  5. Gavilyte - C TM Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Gavilyte - C (polyethylene glycol-3350 and electrolytes with flavor pack) is a ANDA-approved product labeled by Lupin Pharmaceuticals,inc.. This medication is typically used as a increased large intestinal motility [pe]. It is supplied as a powder, for solution for oral administration. This product entry covers the primary NDC 43386-060 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43386-060
Proprietary Name:
Gavilyte - C TM
Non-Proprietary Name: [1]
Polyethylene Glycol-3350 And Electrolytes With Flavor Pack
Substance Name: [2]
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Lupin Pharmaceuticals,inc.
Labeler Code:
43386
Product Label ID:
a8b15625-ca7c-4d57-9f36-3ac2a6d13665
FDA Application Number: [6]
ANDA090186
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-06-2009
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 43386-060?

The NDC code 43386-060 is assigned by the FDA to the product Gavilyte - C TM. It is commonly known by its generic name, polyethylene glycol-3350 and electrolytes with flavor pack. This pharmaceutical product is labeled by Lupin Pharmaceuticals,inc. and is currently categorized as listed product. The medication is a powder, for solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43386-060-19. 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?

GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

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: 966914 - polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 227.41 GM Powder for Oral Solution
  • RxCUI: 966914 - polyethylene glycol 3350 240000 MG / potassium chloride 2980 MG / sodium bicarbonate 6720 MG / sodium chloride 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution
  • RxCUI: 966914 - POLYETHYLENE GLYCOL 3350 240000 MG / K+ Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution
  • RxCUI: 966914 - POLYETHYLENE GLYCOL 3350 240000 MG / Pot Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution
  • RxCUI: 967023 - Gavilyte-C 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.
[Learn More]


* 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 is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".