Immune System Moderator
NDC Package 84611-101-01

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

Immune System Moderator is use to: Regulate the human immune system; Treat rheumatoid arthritis. Marketed by Sanaura Group Limited, this product is identified by NDC 84611-101.

Identification & Billing

NDC Package Code
84611-101-01
Package Description
10 g in 1 BAG
Product Code
84611-101
11-Digit Billing Format
84611010101

Clinical Specifications

Proprietary Name
Immune System Moderator
Dosage Form
-
Usage Information
Use to: Regulate the human immune system; Treat rheumatoid arthritis

Regulatory & Marketing

Labeler Name
Sanaura Group Limited
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-15-2024
Listing Expiration
12-31-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84611-101). Click a package code to view its specific billing and regulatory data.

84611-101-02
10 g in 1 BOTTLE

* 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 84611-101-01 identifies a specific commercial package of 10 g in 1 bag of Immune System Moderator, labeled by Sanaura Group Limited. 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 Sanaura Group Limited on August 15, 2024. The current certification is valid through December 31, 2025.

How is this Sanaura Group Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84611010101. 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)
84611-101-01
11-Digit CMS (5-4-2)
84611-0101-01

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