NDC Package 63629-2518-1 Alosetron

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

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:
63629-2518-1
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Alosetron
Non-Proprietary Name:
Alosetron
Substance Name:
Alosetron Hydrochloride
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, 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 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.
11-Digit NDC Billing Format:
63629251801
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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA213614
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-14-2020
    Listing Expiration Date:
    12-31-2025
    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 63629-2518-1?

    The NDC Packaged Code 63629-2518-1 is assigned to a package of 30 tablet in 1 bottle of Alosetron, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet and is administered via oral form.

    Is NDC 63629-2518 included in the NDC Directory?

    Yes, Alosetron with product code 63629-2518 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on September 14, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63629-2518-1?

    The 11-digit format is 63629251801. 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 5-4-1 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
    5-4-163629-2518-15-4-263629-2518-01