Rotex
NDC Package 69379-038-01

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.

Rotex is iNDICATIONS For the temporary relief of minor pain of muscles and joints associated with: ArthritisSimple BackacheStrains SprainsBruises. Marketed by Home Aide Diagnostics, Inc., this product is identified by NDC 69379-038 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
69379-038-01
Package Description
120 g in 1 BOTTLE, PLASTIC
Product Code
69379-038
11-Digit Billing Format
69379003801
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
120 GM
RxNorm Crosswalk
  • RxCUI: 1660761 - capsaicin 0.038 % / menthol 4 % / methyl salicylate 35 % Topical Cream
  • RxCUI: 1660761 - capsaicin 0.38 MG/ML / menthol 40 MG/ML / methyl salicylate 350 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Rotex
Dosage Form
-
Usage Information
INDICATIONS For the temporary relief of minor pain of muscles and joints associated with: ArthritisSimple BackacheStrains SprainsBruises

Regulatory & Marketing

Labeler Name
Home Aide Diagnostics, Inc.
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-10-2015
Listing Expiration
12-31-2017
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 69379-038-01 identifies a specific commercial package of 120 g in 1 bottle, plastic of Rotex, labeled by Home Aide Diagnostics, Inc.. This product is billed per "GM" gram and contains an estimated amount of 120 billable units per package. 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 Home Aide Diagnostics, Inc. on August 10, 2015. The current certification is valid through December 31, 2017.

How is this Home Aide Diagnostics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69379003801. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 120 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)
69379-038-01
11-Digit CMS (5-4-2)
69379-0038-01

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