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  5. NDC Package Code: 64980-453-50 Alosetron Hydrochloride

NDC Package 64980-453-50 Alosetron Hydrochloride

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
64980-453-50
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
64980-453
Proprietary Name:
Alosetron Hydrochloride
Non-Proprietary Name:
Alosetron Hydrochloride
Substance Name:
Alosetron Hydrochloride
Usage Information:
Alosetron hydrochloride 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, 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 alosetron hydrochloride 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 hydrochloride tablets in men.
11-Digit NDC Billing Format:
64980045350
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:
    Rising 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 .5 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:
    ANDA209180
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-14-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    64980-453-0330 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64980-453-50?

    The NDC Packaged Code 64980-453-50 is assigned to a package of 500 tablet in 1 bottle of Alosetron Hydrochloride, a human prescription drug labeled by Rising Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 64980-453 included in the NDC Directory?

    Yes, Alosetron Hydrochloride with product code 64980-453 is active and included in the NDC Directory. The product was first marketed by Rising Pharmaceuticals, Inc. on January 14, 2019 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 64980-453-50?

    The 11-digit format is 64980045350. 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
    5-3-264980-453-505-4-264980-0453-50