Amitiza
NDC Package 69189-0086-1

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Amitiza is a medication used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-0086 and is authorized under FDA application NDA021908.

Identification & Billing

NDC Package Code
69189-0086-1
Package Description
1 CAPSULE, GELATIN COATED in 1 DOSE PACK
Product Code
69189-0086
11-Digit Billing Format
69189008601

Clinical Specifications

Proprietary Name
Amitiza
Dosage Form
-
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
Avera Mckennan Hospital
FDA Application #
NDA021908
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-06-2015
End Marketing Date
05-24-2017
Listing Expiration
05-24-2017
Exclude Flag
D
Sample Package
No

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 69189-0086-1 identifies a specific commercial package of 1 capsule, gelatin coated in 1 dose pack of Amitiza, labeled by Avera Mckennan Hospital. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avera Mckennan Hospital on April 06, 2015. The current certification is valid through May 24, 2017.

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 Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189008601. 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)
69189-0086-1
11-Digit CMS (5-4-2)
69189-0086-01

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