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  5. NDC Package Code: 54092-476-02 Lialda

NDC Package 54092-476-02 Lialda

Mesalamine Tablet, Delayed Release 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:
54092-476-02
Package Description:
12 BOTTLE in 1 CARTON / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
Product Code:
54092-476
Proprietary Name:
Lialda
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:
54092047602
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
12 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
  • RxCUI: 686433 - Lialda 1. 2 GM Delayed Release Oral Tablet, Once-Daily
  • RxCUI: 686433 - mesalamine 1200 MG Delayed Release Oral Tablet [Lialda]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Takeda Pharmaceuticals America, 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:
    NDA022000
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-16-2007
    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
    54092-476-01120 TABLET, DELAYED RELEASE in 1 BOTTLE
    54092-476-083 CARTON in 1 CARTON / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
    54092-476-12120 TABLET, DELAYED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54092-476-02?

    The NDC Packaged Code 54092-476-02 is assigned to a package of 12 bottle in 1 carton / 120 tablet, delayed release in 1 bottle (54092-476-01) of Lialda, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 54092-476 included in the NDC Directory?

    Yes, Lialda with product code 54092-476 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on January 16, 2007 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 54092-476-02?

    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 12.

    What is the 11-digit format for NDC 54092-476-02?

    The 11-digit format is 54092047602. 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
    5-3-254092-476-025-4-254092-0476-02