Theraderm Pain Relieving Patch
NDC Package 16903-168-01

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.

Theraderm Pain Relieving Patch is adults and children 12 years and over apply to affected area, change patch 2 to 3 times daily.Children under 12 years ask a doctor before use.How to apply:Clean and dry affected area.Cut open poutch and remove patch.If desired, cut patch to size.remove protective film from adhesive, apply directly onto site of pain, and secure ith adhesive strips. Marketed by Manna Omni International Incorporated, this product is identified by NDC 16903-168.

Identification & Billing

NDC Package Code
16903-168-01
Package Description
5 PATCH in 1 PACKAGE
Product Code
16903-168
11-Digit Billing Format
16903016801

Clinical Specifications

Proprietary Name
Theraderm Pain Relieving Patch
Dosage Form
-
Usage Information
Adults and children 12 years and over apply to affected area, change patch 2 to 3 times daily.Children under 12 years ask a doctor before use.How to apply:Clean and dry affected area.Cut open poutch and remove patch.If desired, cut patch to size.remove protective film from adhesive, apply directly onto site of pain, and secure ith adhesive strips.

Regulatory & Marketing

Labeler Name
Manna Omni International Incorporated
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
06-05-2014
Listing Expiration
12-31-2019
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 16903-168-01 identifies a specific commercial package of 5 patch in 1 package of Theraderm Pain Relieving Patch, labeled by Manna Omni International Incorporated. 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 Manna Omni International Incorporated on June 05, 2014. The current certification is valid through December 31, 2019.

How is this Manna Omni International Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16903016801. 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)
16903-168-01
11-Digit CMS (5-4-2)
16903-0168-01

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