Mesalamine Suppository
NDC Package 16571-246-72

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

Package Information

Mesalamine suppositories is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a suppository delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-246 and is authorized under FDA application ANDA219028.

Identification & Billing

NDC Package Code
16571-246-72
Package Description
12 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)
Product Code
16571-246
11-Digit Billing Format
16571024672
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesalamine
Non-Proprietary Name
Mesalamine
Substance Name
Mesalamine
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
MESALAMINE 1000 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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219028
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16571-246). Click a package code to view its specific billing and regulatory data.

16571-246-03
5 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)

* 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 16571-246-72 identifies a specific commercial package of 12 blister pack in 1 carton / 6 suppository in 1 blister pack (16571-246-16) of Mesalamine, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This suppository 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 Rising Pharma Holdings, Inc. on April 14, 2025. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571024672. 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)
16571-246-72
11-Digit CMS (5-4-2)
16571-0246-72

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