12 Cell Salts Complex Pellet
NDC Package 76472-4100-1

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

Package Information

12 Cell Salts Complex (calcarea fluorica, calcarea phosphorica, calcarea sulphurica, ferrum phosphoricum, kali muriaticum, kali phosphoricum, kali sulphuricum, magnesia phosphorica, natrum muriaticum, natrum phosphoricum, natrum sulphuricum, silicea) pellets is (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician. This formulation utilizes a pellet delivery system. Marketed by Sevene Usa, this product is identified by NDC 76472-4100.

Identification & Billing

NDC Package Code
76472-4100-1
Package Description
80 PELLET in 1 CYLINDER
Product Code
76472-4100
11-Digit Billing Format
76472410001

Clinical Specifications

Proprietary Name
12 Cell Salts Complex
Non-Proprietary Name
Calcarea Fluorica, Calcarea Phosphorica, Calcarea Sulphurica, Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Silicea
Substance Name
Calcium Fluoride; Calcium Sulfate Anhydrous; Dibasic Potassium Phosphate; Ferrosoferric Phosphate; Magnesium Phosphate, Dibasic Trihydrate; Potassium Chloride; Potassium Sulfate; Silicon Dioxide; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate; Sodium Sulfate; Tribasic Calcium Phosphate
Dosage Form
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
Usage Information
(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Regulatory & Marketing

Labeler Name
Sevene Usa
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
06-26-2023
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 76472-4100-1 identifies a specific commercial package of 80 pellet in 1 cylinder of 12 Cell Salts Complex, a human over the counter drug labeled by Sevene Usa. This pellet is formulated for sublingual use and contains calcium fluoride; calcium sulfate anhydrous; dibasic potassium phosphate; ferrosoferric phosphate; magnesium phosphate, dibasic trihydrate; potassium chloride; potassium sulfate; silicon dioxide; sodium chloride; sodium phosphate, dibasic, heptahydrate; sodium sulfate; tribasic calcium phosphate 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 Sevene Usa on June 26, 2023. The current certification is valid through December 31, 2026.

How is this Sevene Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76472410001. 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 (5-4-1)
76472-4100-1
11-Digit CMS (5-4-2)
76472-4100-01

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