Simethicone
NDC Package 17856-0791-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Simethicone is a medication used to relieve symptoms of extra gas such as belching, bloating, and feelings of pressure/discomfort in the stomach/gut. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0791 and is authorized under FDA application part332.

Identification & Billing

NDC Package Code
17856-0791-1
Package Description
50 POUCH in 1 BOX / 1 TABLET, CHEWABLE in 1 POUCH (17856-0791-2)
Product Code
17856-0791
11-Digit Billing Format
17856079101
RxNorm Crosswalk
RxCUI: 314216 - simethicone 80 MG Chewable Tablet

Clinical Specifications

Proprietary Name
Simethicone
Dosage Form
-
Usage Information
This product is used to relieve symptoms of extra gas such as belching, bloating, and feelings of pressure/discomfort in the stomach/gut. Simethicone helps break up gas bubbles in the gut.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
part332
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-10-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 17856-0791-1 identifies a specific commercial package of 50 pouch in 1 box / 1 tablet, chewable in 1 pouch (17856-0791-2) of Simethicone, labeled by Atlantic Biologicals Corp.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corp. on February 10, 2022. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

This product is used to relieve symptoms of extra gas such as belching, bloating, and feelings of pressure/discomfort in the stomach/gut. Simethicone helps break up gas bubbles in the gut.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856079101. 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 (5-4-1)
17856-0791-1
11-Digit CMS (5-4-2)
17856-0791-01

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