Mesalamine Rectal Suppository
NDC Package 69918-560-30

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

Package Information

Mesalamine Rectal (mesalamine) suppositories is a medication used to treat a certain bowel disease (ulcerative colitis). This formulation utilizes a suppository delivery system. Marketed by Amring Pharmaceuticals Inc., this product is identified by NDC 69918-560 and is authorized under FDA application ANDA208362.

Identification & Billing

NDC Package Code
69918-560-30
Package Description
30 SUPPOSITORY in 1 BOX
Product Code
69918-560
11-Digit Billing Format
69918056030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mesalamine Rectal
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
Amring Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208362
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-24-2019
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 69918-560-30 identifies a specific commercial package of 30 suppository in 1 box of Mesalamine Rectal, a human prescription drug labeled by Amring Pharmaceuticals 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 Amring Pharmaceuticals Inc. on June 24, 2019. 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 Amring Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69918056030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
69918-560-30
11-Digit CMS (5-4-2)
69918-0560-30

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