Lotronex
NDC Package 54766-894-03

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.

Lotronex is alosetron is used to treat women with severe irritable bowel syndrome (IBS) who have diarrhea as the main problem. Marketed by Sebela Pharmaceuticals Inc., this product is identified by NDC 54766-894 and is authorized under FDA application NDA021107.

Identification & Billing

NDC Package Code
54766-894-03
Package Description
30 TABLET in 1 BOTTLE
Product Code
54766-894
11-Digit Billing Format
54766089403
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Lotronex
Dosage Form
-
Usage Information
Alosetron is used to treat women with severe irritable bowel syndrome (IBS) who have diarrhea as the main problem. It is not a cure, but it may help to decrease abdominal pain, sudden urges to have a bowel movement, and diarrhea. This medication is not recommended for use by children because of the serious side effects that have been seen in adults.

Regulatory & Marketing

Labeler Name
Sebela Pharmaceuticals Inc.
FDA Application #
NDA021107
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-11-2016
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
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 54766-894-03 identifies a specific commercial package of 30 tablet in 1 bottle of Lotronex, labeled by Sebela Pharmaceuticals Inc.. 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 Sebela Pharmaceuticals Inc. on July 11, 2016. The current certification is valid through April 30, 2026.

What are the primary indications for this medication?

Alosetron is used to treat women with severe irritable bowel syndrome (IBS) who have diarrhea as the main problem. It is not a cure, but it may help to decrease abdominal pain, sudden urges to have a bowel movement, and diarrhea. This medication is not recommended for use by children because of the serious side effects that have been seen in adults.

How is this Sebela Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54766089403. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
54766-894-03
11-Digit CMS (5-4-2)
54766-0894-03

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