Simethicone Liquid
NDC Package 44331-1101-2

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Simethicone liquids is a medication used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. This formulation utilizes a liquid delivery system. Marketed by Riocare India Pvt Ltd, this product is identified by NDC 44331-1101.

Identification & Billing

NDC Package Code
44331-1101-2
Package Description
30 kg in 1 DRUM
Product Code
44331-1101
11-Digit Billing Format
44331110102

Clinical Specifications

Proprietary Name
Simethicone
Non-Proprietary Name
Simethicone
Substance Name
Dimethicone
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
Usage Information
This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

Regulatory & Marketing

Labeler Name
Riocare India Pvt Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-03-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (44331-1101). Click a package code to view its specific billing and regulatory data.

44331-1101-1
50 kg in 1 DRUM
44331-1101-3
200 kg in 1 DRUM
44331-1101-4
5 kg in 1 JAR

* 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 44331-1101-2 identifies a specific commercial package of 30 kg in 1 drum of Simethicone (UNFINISHED drug), a bulk ingredient labeled by Riocare India Pvt Ltd. This liquid is formulated for use and contains dimethicone 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 Riocare India Pvt Ltd on August 03, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

How is this Riocare India Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44331110102. 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)
44331-1101-2
11-Digit CMS (5-4-2)
44331-1101-02

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