Lubiprostone Capsule, Gelatin Coated
NDC Package 72189-607-60

11-digit billing NDC: 72189060760 · Billing unit: EA · 60 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lubiprostone capsules is 1.1 Chronic Idiopathic Constipation in AdultsLubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer PainLubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.Limitations of Use:Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-607 and is authorized under FDA application NDA021908.

Identification & Billing

NDC Package Code
72189-607-60
Package Description
60 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
72189-607
11-Digit Billing Format
72189060760
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LUBIPROSTONE 24 ug/1
Pharmacologic Class
Usage Information
1.1 Chronic Idiopathic Constipation in AdultsLubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer PainLubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.Limitations of Use:Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2)]1.3 Irritable Bowel Syndrome with ConstipationLubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.

Regulatory & Marketing

Labeler Name
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
NDA021908
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-16-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-607-60 identifies a specific commercial package of 60 capsule, gelatin coated in 1 bottle of Lubiprostone, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Direct Rx on January 16, 2025. The current certification is valid through December 31, 2026.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189060760. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
72189-607-60
11-Digit CMS (5-4-2)
72189-0607-60

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