Mesalamine Powder
NDC Package 42419-024-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Mesalamine powders is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a powder delivery system. Marketed by Ctx Lifesciences Pvt. Ltd., this product is identified by NDC 42419-024.

Identification & Billing

NDC Package Code
42419-024-01
Package Description
25 kg in 1 DRUM
Product Code
42419-024
11-Digit Billing Format
42419002401

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
MESALAMINE 25 kg/25kg
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.

Regulatory & Marketing

Labeler Name
Ctx Lifesciences Pvt. Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-04-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42419-024-01 identifies a specific commercial package of 25 kg in 1 drum of Mesalamine (UNFINISHED drug), a bulk ingredient labeled by Ctx Lifesciences Pvt. Ltd.. This powder is formulated for use and contains mesalamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ctx Lifesciences Pvt. Ltd. on February 04, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Ctx Lifesciences Pvt. Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42419002401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42419-024-01
11-Digit CMS (5-4-2)
42419-0024-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.