Lotronex Tablet
NDC Package 83107-013-30

11-digit billing NDC: 83107001330
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lotronex (alosetron hydrochloride) tablets is lOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:chronic IBS symptoms (generally lasting 6 months or longer),had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, andnot responded adequately to conventional therapy.Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:frequent and severe abdominal pain/discomfort,frequent bowel urgency or fecal incontinence,disability or restriction of daily activities due to IBS.Because of infrequent but serious gastrointestinal adverse reactions associated with LOTRONEX, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men. This formulation utilizes a tablet delivery system. Marketed by Legacy Pharma Usa Inc., this product is identified by NDC 83107-013 and is authorized under FDA application NDA021107.

Identification & Billing

NDC Package Code
83107-013-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
83107-013
11-Digit Billing Format
83107001330
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lotronex
Non-Proprietary Name
Alosetron Hydrochloride
Substance Name
Alosetron Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALOSETRON HYDROCHLORIDE .5 mg/1
Pharmacologic Class
Usage Information
LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:chronic IBS symptoms (generally lasting 6 months or longer),had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, andnot responded adequately to conventional therapy.Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:frequent and severe abdominal pain/discomfort,frequent bowel urgency or fecal incontinence,disability or restriction of daily activities due to IBS.Because of infrequent but serious gastrointestinal adverse reactions associated with LOTRONEX, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men.

Regulatory & Marketing

Labeler Name
Legacy Pharma Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021107
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83107-013-30 identifies a specific commercial package of 30 tablet in 1 bottle of Lotronex, a human prescription drug labeled by Legacy Pharma Usa Inc.. This tablet is formulated for oral use and contains alosetron hydrochloride 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 Legacy Pharma Usa Inc. on January 01, 2026. The current certification is valid through December 31, 2027.

How is this Legacy Pharma Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107001330. 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)
83107-013-30
11-Digit CMS (5-4-2)
83107-0013-30

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