Lubiprostone Capsule, Gelatin Coated
NDC Package 11014-0010-1

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.

Lubiprostone capsules is a medication used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Catalent Pharma Solutions, Llc, this product is identified by NDC 11014-0010.

Identification & Billing

NDC Package Code
11014-0010-1
Package Description
1 BAG in 1 BAG / 30000 CAPSULE, GELATIN COATED in 1 BAG
Product Code
11014-0010
11-Digit Billing Format
11014001001

Clinical Specifications

Proprietary Name
Lubiprostone
Non-Proprietary Name
Lubiprostone
Substance Name
Lubiprostone
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)
LUBIPROSTONE 8 ug/1
Usage Information
This medication is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. This medication may improve symptoms such as bloating and abdominal discomfort, improve stool texture, lessen the need to strain, and decrease the feeling of not completely relieving oneself. Lubiprostone belongs to a class of drugs known as chloride channel activators. It works by increasing the amount of fluid within your intestines, making the passage of stool easier.

Regulatory & Marketing

Labeler Name
Catalent Pharma Solutions, Llc
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
01-31-2006
Listing Expiration
12-31-2027
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 11014-0010-1 identifies a specific commercial package of 1 bag in 1 bag / 30000 capsule, gelatin coated in 1 bag of Lubiprostone (UNFINISHED drug), drug for further processing labeled by Catalent Pharma Solutions, Llc. This capsule, gelatin coated is formulated for use and contains lubiprostone 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 Catalent Pharma Solutions, Llc on January 31, 2006. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. This medication may improve symptoms such as bloating and abdominal discomfort, improve stool texture, lessen the need to strain, and decrease the feeling of not completely relieving oneself. Lubiprostone belongs to a class of drugs known as chloride channel activators. It works by increasing the amount of fluid within your intestines, making the passage of stool easier.

How is this Catalent Pharma Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11014001001. 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 (5-4-1)
11014-0010-1
11-Digit CMS (5-4-2)
11014-0010-01

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