Amitiza Capsule, Gelatin Coated
NDC Package 64764-080-40

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

Amitiza (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 Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-080 and is authorized under FDA application NDA021908.

Identification & Billing

NDC Package Code
64764-080-40
Package Description
4 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
64764-080
11-Digit Billing Format
64764008040
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amitiza
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LUBIPROSTONE 8 ug/1
Pharmacologic Class
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
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021908
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-31-2006
End Marketing Date
03-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64764-080). Click a package code to view its specific billing and regulatory data.

64764-080-60
60 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 64764-080-40 identifies a specific commercial package of 4 carton in 1 carton / 1 blister pack in 1 carton / 4 capsule, gelatin coated in 1 blister pack of Amitiza, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This capsule, gelatin coated is formulated for oral 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 Takeda Pharmaceuticals America, Inc. on January 31, 2006.

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 Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764008040. 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 (5-3-2)
64764-080-40
11-Digit CMS (5-4-2)
64764-0080-40

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