Arnica Active Montana Nartex Gel
NDC Package 34666-407-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Arnica Active Montana Nartex (arnica montana, hamamelis virginiana) gel is adults and children over 2 years of age: apply generously rubbing into affected area as needed.children 2 years of age: consult a physician. This formulation utilizes a gel delivery system. Marketed by Nartex Laboratorios Homeopaticos, S.a. De C.v., this product is identified by NDC 34666-407.

Identification & Billing

NDC Package Code
34666-407-01
Package Description
1 TUBE in 1 CARTON / 74 g in 1 TUBE
Product Code
34666-407
11-Digit Billing Format
34666040701

Clinical Specifications

Proprietary Name
Arnica Active Montana Nartex
Non-Proprietary Name
Arnica Montana, Hamamelis Virginiana
Substance Name
Arnica Montana; Hamamelis Virginiana Root Bark/stem Bark
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Adults and children over 2 years of age: apply generously rubbing into affected area as needed.children 2 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Nartex Laboratorios Homeopaticos, S.a. De C.v.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
12-30-2021
Listing Expiration
12-31-2026
Exclude Flag
N
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 34666-407-01 identifies a specific commercial package of 1 tube in 1 carton / 74 g in 1 tube of Arnica Active Montana Nartex, a human over the counter drug labeled by Nartex Laboratorios Homeopaticos, S.a. De C.v.. This gel is formulated for topical use and contains arnica montana; hamamelis virginiana root bark/stem bark as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nartex Laboratorios Homeopaticos, S.a. De C.v. on December 30, 2021. The current certification is valid through December 31, 2026.

How is this Nartex Laboratorios Homeopaticos, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34666040701. 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)
34666-407-01
11-Digit CMS (5-4-2)
34666-0407-01

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