Simplex Tablet
NDC Package 34666-008-60

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

Package Information

Simplex (passiflora incarnata, ignatia amara, valeriana officinalis) tablets is for relief of symptoms of sleeplessness and stress as per homeopathic materia medica. This formulation utilizes a tablet delivery system. Marketed by Nartex Laboratories, this product is identified by NDC 34666-008.

Identification & Billing

NDC Package Code
34666-008-60
Package Description
60 TABLET in 1 BOX
Product Code
34666-008
11-Digit Billing Format
34666000860

Clinical Specifications

Proprietary Name
Simplex
Non-Proprietary Name
Passiflora Incarnata, Ignatia Amara, Valeriana Officinalis
Substance Name
Passiflora Incarnata Flower; Strychnos Ignatii Seed; Valerian
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
For relief of symptoms of sleeplessness and stress as per homeopathic materia medica

Regulatory & Marketing

Labeler Name
Nartex Laboratories
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
12-23-2010
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (34666-008). Click a package code to view its specific billing and regulatory data.

34666-008-06
6 TABLET in 1 BOX

* 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 34666-008-60 identifies a specific commercial package of 60 tablet in 1 box of Simplex, a human over the counter drug labeled by Nartex Laboratories. This tablet is formulated for oral use and contains passiflora incarnata flower; strychnos ignatii seed; valerian 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 Laboratories on December 23, 2010. The current certification is valid through December 31, 2026.

How is this Nartex Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34666000860. 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)
34666-008-60
11-Digit CMS (5-4-2)
34666-0008-60

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