Mesalamine Kit
NDC Package 45802-929-49

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

Package Information

Mesalamine kits is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a kit delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-929 and is authorized under FDA application ANDA076751.

Identification & Billing

NDC Package Code
45802-929-49
Package Description
4 CARTON in 1 KIT / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
Product Code
45802-929
11-Digit Billing Format
45802092949
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Dosage Form
Kit - A packaged collection of related material.
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA076751
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-02-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 45802-929-49 identifies a specific commercial package of 4 carton in 1 kit / 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 Padagis Israel Pharmaceuticals Ltd. This kit is formulated for use and contains 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 Padagis Israel Pharmaceuticals Ltd on August 02, 2018. 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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802092949. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
45802-929-49
11-Digit CMS (5-4-2)
45802-0929-49

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