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  5. NDC Package Code: 54766-895-03 Lotronex

NDC Package 54766-895-03 Lotronex

Alosetron Hydrochloride Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54766-895-03
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
54766-895
Proprietary Name:
Lotronex
Non-Proprietary Name:
Alosetron Hydrochloride
Substance Name:
Alosetron Hydrochloride
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.
11-Digit NDC Billing Format:
54766089503
NDC to RxNorm Crosswalk:
  • RxCUI: 259306 - alosetron HCl 1 MG Oral Tablet
  • RxCUI: 259306 - alosetron 1 MG Oral Tablet
  • RxCUI: 259306 - alosetron 1 MG (as alosetron HCl 1.124 MG) Oral Tablet
  • RxCUI: 261362 - Lotronex 1 MG Oral Tablet
  • RxCUI: 261362 - alosetron 1 MG Oral Tablet [Lotronex]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sebela Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ALOSETRON HYDROCHLORIDE 1 mg/1
    • Pharmacologic Class(es):
  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA021107
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-11-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 54766-895-03?

    The NDC Packaged Code 54766-895-03 is assigned to a package of 30 tablet in 1 bottle of Lotronex, a human prescription drug labeled by Sebela Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54766-895 included in the NDC Directory?

    Yes, Lotronex with product code 54766-895 is active and included in the NDC Directory. The product was first marketed by Sebela Pharmaceuticals Inc. on July 11, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54766-895-03?

    The 11-digit format is 54766089503. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-254766-895-035-4-254766-0895-03