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  5. NDC Package Code: 63304-175-13 Mesalamine

NDC Package 63304-175-13 Mesalamine

Tablet, Delayed Release 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:
63304-175-13
Package Description:
120 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
63304-175
Proprietary Name:
Mesalamine
Non-Proprietary Name:
Mesalamine
Substance 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:
63304017513
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 686429 - mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily
  • RxCUI: 686429 - mesalamine 1200 MG Delayed Release Oral Tablet
  • RxCUI: 686429 - mesalazine 1.2 GM Delayed Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MESALAMINE 1.2 g/1
    • Pharmacologic Class(es):
  • Aminosalicylate - [EPC] (Established Pharmacologic Class)
  • Aminosalicylic Acids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA211858
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-2019
    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.

    Frequently Asked Questions

    What is NDC 63304-175-13?

    The NDC Packaged Code 63304-175-13 is assigned to a package of 120 tablet, delayed release in 1 bottle of Mesalamine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 63304-175 included in the NDC Directory?

    Yes, Mesalamine with product code 63304-175 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on February 01, 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 NDC billing unit for package 63304-175-13?

    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 120.

    What is the 11-digit format for NDC 63304-175-13?

    The 11-digit format is 63304017513. 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
    5-3-263304-175-135-4-263304-0175-13