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  5. NDC Package Code: 0456-1203-04 Linzess

NDC Package 0456-1203-04 Linzess

Linaclotide Capsule, Gelatin Coated 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:
0456-1203-04
Package Description:
1 BOTTLE in 1 CARTON / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code:
0456-1203
Proprietary Name:
Linzess
Non-Proprietary Name:
Linaclotide
Substance Name:
Linaclotide
Usage Information:
See also Warning section. Linaclotide is used to treat certain types of bowel problems (irritable bowel syndrome with constipation, chronic idiopathic constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Linaclotide may improve stool texture and lessen symptoms such as bloating, abdominal pain/discomfort, 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:
00456120304
NDC to RxNorm Crosswalk:
  • RxCUI: 1307409 - linaclotide 145 MCG Oral Capsule
  • RxCUI: 1307409 - linaclotide 0.145 MG Oral Capsule
  • RxCUI: 1307415 - Linzess 145 MCG Oral Capsule
  • RxCUI: 1307415 - linaclotide 0.145 MG Oral Capsule [Linzess]
  • RxCUI: 1307415 - Linzess 0.145 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Allergan, Inc.
    Dosage Form:
    Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LINACLOTIDE 72 ug/1
    • Pharmacologic Class(es):
  • Guanylate Cyclase Activators - [MoA] (Mechanism of Action)
  • Guanylate Cyclase-C Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA202811
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-30-2017
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0456-1203-301 BOTTLE in 1 CARTON / 30 CAPSULE, GELATIN COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0456-1203-04?

    The NDC Packaged Code 0456-1203-04 is assigned to a package of 1 bottle in 1 carton / 4 capsule, gelatin coated in 1 bottle of Linzess, a human prescription drug labeled by Allergan, Inc.. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 0456-1203 included in the NDC Directory?

    Yes, Linzess with product code 0456-1203 is active and included in the NDC Directory. The product was first marketed by Allergan, Inc. on January 30, 2017 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 11-digit format for NDC 0456-1203-04?

    The 11-digit format is 00456120304. 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 4-4-2 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
    4-4-20456-1203-045-4-200456-1203-04