Gavilyte - C Powder, For Solution
NDC Package 43386-060-19

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

Package Information

Gavilyte - C (polyethylene glycol-3350 and electrolytes with flavor pack) powders is gaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. This formulation utilizes a powder, for solution delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-060 and is authorized under FDA application ANDA090186.

Identification & Billing

NDC Package Code
43386-060-19
Package Description
278.26 g in 1 BOTTLE
Product Code
43386-060
11-Digit Billing Format
43386006019
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Gavilyte - C TM
Non-Proprietary Name
Polyethylene Glycol-3350 And Electrolytes With Flavor Pack
Substance Name
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090186
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43386-060-19 identifies a specific commercial package of 278.26 g in 1 bottle of Gavilyte - C TM, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous 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 Lupin Pharmaceuticals,inc. on January 06, 2009. The current certification is valid through December 31, 2026.

How is this Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386006019. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
43386-060-19
11-Digit CMS (5-4-2)
43386-0060-19

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