Novana Wash Perineal Skin Cleanser
NDC Package 76077-100-04

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.

Novana Wash Perineal Skin Cleanser is directions Cleanse the affected area according to protocol. Marketed by Novana Medical Llc, this product is identified by NDC 76077-100 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
76077-100-04
Package Description
120 mL in 1 BOTTLE, SPRAY
Product Code
76077-100
11-Digit Billing Format
76077010004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Novana Wash Perineal Skin Cleanser
Dosage Form
-
Usage Information
Directions Cleanse the affected area according to protocol.

Regulatory & Marketing

Labeler Name
Novana Medical Llc
FDA Application #
part333E
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
04-04-2012
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 76077-100-04 identifies a specific commercial package of 120 ml in 1 bottle, spray of Novana Wash Perineal Skin Cleanser, labeled by Novana Medical Llc. This product is billed per "ML" milliliter 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 Novana Medical Llc on April 04, 2012. The current certification is valid through December 31, 2017.

How is this Novana Medical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76077010004. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
76077-100-04
11-Digit CMS (5-4-2)
76077-0100-04

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