Mesalamine Tablet, Delayed Release
NDC Package 42291-489-18

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

Package Information

Mesalamine tablets is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a tablet, delayed release delivery system. Marketed by Avkare, this product is identified by NDC 42291-489 and is authorized under FDA application ANDA213191.

Identification & Billing

NDC Package Code
42291-489-18
Package Description
180 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
42291-489
11-Digit Billing Format
42291048918
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MESALAMINE 800 mg/1
Pharmacologic Class
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
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA213191
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2024
Listing Expiration
12-31-2027
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 42291-489-18 identifies a specific commercial package of 180 tablet, delayed release in 1 bottle of Mesalamine, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. This tablet, delayed release is formulated for oral 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 Avkare on September 25, 2024. The current certification is valid through December 31, 2027.

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 Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291048918. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 total billable units per package. 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)
42291-489-18
11-Digit CMS (5-4-2)
42291-0489-18

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