Alosetron Hydrochloride Tablet, Film Coated
NDC Package 53746-249-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alosetron Hydrochloride tablets is alosetron tablets are 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, and not responded adequately to conventional therapy. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-249 and is authorized under FDA application ANDA206647.

Identification & Billing

NDC Package Code
53746-249-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
53746-249
11-Digit Billing Format
53746024930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alosetron Hydrochloride
Non-Proprietary Name
Alosetron Hydrochloride
Substance Name
Alosetron Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALOSETRON HYDROCHLORIDE 1 mg/1
Pharmacologic Class
Usage Information
Alosetron tablets are 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, and not 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 alosetron tablets, 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 alosetron tablets in men.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206647
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-06-2023
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 53746-249-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Alosetron Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet, film coated 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 Amneal Pharmaceuticals Of New York Llc on September 06, 2023. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746024930. 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)
53746-249-30
11-Digit CMS (5-4-2)
53746-0249-30

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