1. Home
  2. Labeler Index
  3. Lupin Pharmaceuticals,inc.
  4. 43386-060
  5. NDC Package Code: 43386-060-19 Gavilyte - C TM

NDC Package 43386-060-19 Gavilyte - C TM

Polyethylene Glycol-3350 And Electrolytes With Flavor Pack Powder, For Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43386-060-19
Package Description:
278.26 g in 1 BOTTLE
Product Code:
43386-060
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
Usage Information:
GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
11-Digit NDC Billing Format:
43386006019
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • POLYETHYLENE GLYCOL 3350 240 g/278.26g
  • POTASSIUM CHLORIDE 2.98 g/278.26g
  • SODIUM BICARBONATE 6.72 g/278.26g
  • SODIUM CHLORIDE 5.84 g/278.26g
  • SODIUM SULFATE ANHYDROUS 22.72 g/278.26g
    • Pharmacologic Class(es):
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090186
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-06-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 43386-060-19?

    The NDC Packaged Code 43386-060-19 is assigned to a package of 278.26 g in 1 bottle of Gavilyte - C TM, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is powder, for solution and is administered via oral form.

    Is NDC 43386-060 included in the NDC Directory?

    Yes, Gavilyte - C TM with product code 43386-060 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on January 06, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43386-060-19?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 43386-060-19?

    The 11-digit format is 43386006019. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243386-060-195-4-243386-0060-19