Linzess Capsule, Gelatin Coated
NDC Package 0456-1202-07

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

Package Information

Linzess (linaclotide) capsules is see also Warning section. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Allergan, Inc., this product is identified by NDC 0456-1202 and is authorized under FDA application NDA202811.

Identification & Billing

NDC Package Code
0456-1202-07
Package Description
1 BOTTLE in 1 CARTON / 7 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0456-1202
11-Digit Billing Format
00456120207
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Linzess
Non-Proprietary Name
Linaclotide
Substance Name
Linaclotide
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LINACLOTIDE 290 ug/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202811
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-08-2012
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0456-1202). Click a package code to view its specific billing and regulatory data.

0456-1202-04
1 BOTTLE in 1 CARTON / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
0456-1202-30
1 BOTTLE in 1 CARTON / 30 CAPSULE, GELATIN COATED in 1 BOTTLE

* 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 0456-1202-07 identifies a specific commercial package of 1 bottle in 1 carton / 7 capsule, gelatin coated in 1 bottle of Linzess, a human prescription drug labeled by Allergan, Inc.. This capsule, gelatin coated is formulated for oral use and contains linaclotide 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 Allergan, Inc. on September 08, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00456120207. 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 (4-4-2)
0456-1202-07
11-Digit CMS (5-4-2)
00456-1202-07

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