Linaclotide Capsule, Gelatin Coated
NDC Package 0456-1206-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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 0456-1206.

Identification & Billing

NDC Package Code
0456-1206-00
Package Description
1 BAG in 1 DRUM / 51000 CAPSULE, GELATIN COATED in 1 BAG
Product Code
0456-1206
11-Digit Billing Format
00456120600

Clinical Specifications

Proprietary Name
Linaclotide
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.
Active Ingredient(s)
LINACLOTIDE 72 ug/1
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
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-30-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0456-1206-00 identifies a specific commercial package of 1 bag in 1 drum / 51000 capsule, gelatin coated in 1 bag of Linaclotide (UNFINISHED drug), drug for further processing labeled by Allergan, Inc.. This capsule, gelatin coated is formulated for 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 January 30, 2017. The current certification is valid through December 31, 2026.

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: 00456120600. 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)
0456-1206-00
11-Digit CMS (5-4-2)
00456-1206-00

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