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  5. NDC Package Code: 65649-003-01 Trulance Immediate Release

NDC Package 65649-003-01 Trulance Immediate Release

Plecanatide Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
65649-003-01
Package Description:
1 BOTTLE in 1 CARTON / 1 TABLET in 1 BOTTLE
Product Code:
65649-003
Proprietary Name:
Trulance Immediate Release
Non-Proprietary Name:
Plecanatide
Substance Name:
Plecanatide
Usage Information:
See also Warning section. Plecanatide is used to treat certain types of bowel problems (chronic idiopathic constipation, irritable bowel syndrome with constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Plecanatide may improve stool texture and lessen symptoms such as straining and feelings of incomplete bowel movements. This medication must not be used in children younger than 6 years because of the risk of serious side effects.
11-Digit NDC Billing Format:
65649000301
NDC to RxNorm Crosswalk:
  • RxCUI: 1873757 - plecanatide 3 MG Oral Tablet
  • RxCUI: 1873765 - Trulance 3 MG Oral Tablet
  • RxCUI: 1873765 - plecanatide 3 MG Oral Tablet [Trulance]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Salix Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PLECANATIDE 3 mg/1
    • Pharmacologic Class(es):
  • Guanylate Cyclase Activators - [MoA] (Mechanism of Action)
  • Guanylate Cyclase-C Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA208745
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-21-2017
    Listing Expiration Date:
    12-31-2025
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65649-003-031 BOTTLE in 1 CARTON / 3 TABLET in 1 BOTTLE
    65649-003-071 BOTTLE in 1 CARTON / 7 TABLET in 1 BOTTLE
    65649-003-3030 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65649-003-01?

    The NDC Packaged Code 65649-003-01 is assigned to a package of 1 bottle in 1 carton / 1 tablet in 1 bottle of Trulance Immediate Release, a human prescription drug labeled by Salix Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65649-003 included in the NDC Directory?

    Yes, Trulance Immediate Release with product code 65649-003 is active and included in the NDC Directory. The product was first marketed by Salix Pharmaceuticals Inc. on February 21, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65649-003-01?

    The 11-digit format is 65649000301. 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
    5-3-265649-003-015-4-265649-0003-01