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  5. NDC Package Code: 63629-8678-1 Mesalamine

NDC Package 63629-8678-1 Mesalamine

Kit - 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:
63629-8678-1
Package Description:
1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
Product Code:
63629-8678
Proprietary Name:
Mesalamine
Non-Proprietary Name:
Mesalamine
Usage Information:
This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.
11-Digit NDC Billing Format:
63629867801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 238151 - mesalamine 4 GM per 60 mL Enema
  • RxCUI: 238151 - mesalamine 66.7 MG/ML Enema
  • RxCUI: 238151 - mesalamine 4 GM per 60 ML Enema
  • RxCUI: 238151 - mesalazine 66.7 MG/ML Enema
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA076751
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-01-2009
    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 63629-8678-1?

    The NDC Packaged Code 63629-8678-1 is assigned to a package of 1 kit in 1 carton * 60 ml in 1 bottle (45802-098-46) * 1 swab in 1 packet of Mesalamine, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is kit and is administered via form.

    Is NDC 63629-8678 included in the NDC Directory?

    Yes, Mesalamine with product code 63629-8678 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on September 01, 2009 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 63629-8678-1?

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

    What is the 11-digit format for NDC 63629-8678-1?

    The 11-digit format is 63629867801. 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
    5-4-163629-8678-15-4-263629-8678-01