Mondoxyne
NDC Package 69668-431-01

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.

Mondoxyne is a . Marketed by Oculus Innovative Sciences, this product is identified by NDC 69668-431 and is authorized under FDA application ANDA204446.

Identification & Billing

NDC Package Code
69668-431-01
Package Description
50 mg in 1 BOTTLE
Product Code
69668-431
11-Digit Billing Format
69668043101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mondoxyne
Dosage Form
-

Regulatory & Marketing

Labeler Name
Oculus Innovative Sciences
FDA Application #
ANDA204446
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2015
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 69668-431-01 identifies a specific commercial package of 50 mg in 1 bottle of Mondoxyne, labeled by Oculus Innovative Sciences. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Oculus Innovative Sciences on May 28, 2015. The current certification is valid through December 31, 2019.

How is this Oculus Innovative Sciences product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69668043101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
69668-431-01
11-Digit CMS (5-4-2)
69668-0431-01

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