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  5. NDC Package Code: 45963-480-03 Alosetron Hydrochloride

NDC Package 45963-480-03 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:
45963-480-03
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
Product Code:
45963-480
Proprietary Name:
Alosetron Hydrochloride
Non-Proprietary Name:
Alosetron Hydrochloride
Substance Name:
Alosetron Hydrochloride
Usage Information:
Alosetron hydrochloride 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, 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 hydrochloride, 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 hydrochloride in men.
11-Digit NDC Billing Format:
45963048003
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
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: 403975 - alosetron HCl 0.5 MG Oral Tablet
  • RxCUI: 403975 - alosetron 0.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actavis Pharma, 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 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:
    05-26-2015
    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 45963-480-03?

    The NDC Packaged Code 45963-480-03 is assigned to a package of 1 bottle in 1 carton / 30 tablet in 1 bottle of Alosetron Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 45963-480 included in the NDC Directory?

    Yes, Alosetron Hydrochloride with product code 45963-480 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on May 26, 2015 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 NDC billing unit for package 45963-480-03?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 45963-480-03?

    The 11-digit format is 45963048003. 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
    5-3-245963-480-035-4-245963-0480-03