NDC Package 43386-071-83 Gavilyte-h And Bisacodyl

Polyethylene Glycol 3350,Sodium Chloride,Sodium Bicarbonate,Potassium Chloride And - View Billable Units, 11-Digit Format, RxNorm

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:
43386-071-83
Package Description:
1 KIT in 1 KIT * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)
Product Code:
Proprietary Name:
Gavilyte-h And Bisacodyl
Non-Proprietary Name:
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl Delayed-release Tablet
Usage Information:
GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
11-Digit NDC Billing Format:
43386007183
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1000479 - {1 (bisacodyl 5 MG Delayed Release Oral Tablet) / 1 (2000 ML) (polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution) } Pack
  • RxCUI: 1000479 - 1 (PEG-3350 210 GM / potassium chloride 0.74 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for Oral Solution) / 1 (bisacodyl 5 MG Delayed Release Oral Tablet) Pack
  • RxCUI: 1000479 - PEG-3350 210 GM / potassium chloride 0.740 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for 2 L Oral Solution / 1 x bisacodyl 5 MG Delayed Release Oral Tablet
  • RxCUI: 1718983 - polyethylene glycol-3350 210 GM / potassium chloride 0.74 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for Oral Solution
  • RxCUI: 1718983 - polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA202217
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-21-2015
    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 43386-071-83?

    The NDC Packaged Code 43386-071-83 is assigned to a package of 1 kit in 1 kit * 1 tablet, delayed release in 1 blister pack (43386-010-61) * 2 l in 1 bottle (43386-070-17) of Gavilyte-h And Bisacodyl, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via oral form.

    Is NDC 43386-071 included in the NDC Directory?

    Yes, Gavilyte-h And Bisacodyl with product code 43386-071 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals, Inc. on April 21, 2015 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 43386-071-83?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 43386-071-83?

    The 11-digit format is 43386007183. 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
    5-3-243386-071-835-4-243386-0071-83