Nixoderm Unguento
NDC Package 70344-001-01

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.

Nixoderm Unguento is for Skin Acne treatmentFor relief, irritation, redness and of AcneIndications:*For the treatment of Acne. Marketed by Laboratorios Incobra S.a., this product is identified by NDC 70344-001 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
70344-001-01
Package Description
20 g in 1 PACKAGE
Product Code
70344-001
11-Digit Billing Format
70344000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nixoderm Unguento
Dosage Form
-
Usage Information
For Skin Acne treatmentFor relief, irritation, redness and of AcneIndications:*For the treatment of Acne.  Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.

Regulatory & Marketing

Labeler Name
Laboratorios Incobra S.a.
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-10-2016
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 70344-001-01 identifies a specific commercial package of 20 g in 1 package of Nixoderm Unguento, labeled by Laboratorios Incobra S.a.. 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 Laboratorios Incobra S.a. on February 10, 2016. The current certification is valid through December 31, 2017.

How is this Laboratorios Incobra S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70344000101. 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)
70344-001-01
11-Digit CMS (5-4-2)
70344-0001-01

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