Mesalamine Enema
NDC Package 62559-420-07

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

Package Information

Mesalamine enemas is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a enema delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 62559-420 and is authorized under FDA application NDA019618.

Identification & Billing

NDC Package Code
62559-420-07
Package Description
7 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE (62559-420-11)
Product Code
62559-420
11-Digit Billing Format
62559042007
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
Dosage Form
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
MESALAMINE 4 g/60mL
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
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019618
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-13-2016
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 62559-420-07 identifies a specific commercial package of 7 bottle in 1 box / 60 ml in 1 bottle (62559-420-11) of Mesalamine, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This enema is formulated for rectal 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 Ani Pharmaceuticals, Inc. on May 13, 2016. 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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559042007. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
62559-420-07
11-Digit CMS (5-4-2)
62559-0420-07

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