Vortex Moisturizer Oral
NDC Package 82529-001-01

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.

Vortex Moisturizer Oral is 12 years old - adult: 3 sprays. Marketed by Vortex Life Sciences, Inc., this product is identified by NDC 82529-001 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
82529-001-01
Package Description
1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
Product Code
82529-001
11-Digit Billing Format
82529000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vortex Moisturizer Oral
Dosage Form
-
Usage Information
12 years old - adult: 3 sprays. 6 - 12 years old: 2 sprays. 3 - 6 years old: 1 spray. Children under age 3: 1 spray. Consult a physician. To use, remove cap, depress the pump completely to spray directly into mouth and throat. Day 1: every 3 hours Day 2: every 3 hours Day 3: 3 times a day Day 4: at bedtime Day 5: at bedtime Day 6 - 9: skip Day 10: at bedtime (final dose) For moderate to severe symptoms every 3 hours (minimum 5 doses/24hrs) until symptoms have significantly reduced. Then, resume at day 3 schedule.

Regulatory & Marketing

Labeler Name
Vortex Life Sciences, Inc.
FDA Application #
part356
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
03-01-2022
Listing Expiration
12-31-2023
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 82529-001-01 identifies a specific commercial package of 1 bottle in 1 box / 15 ml in 1 bottle of Vortex Moisturizer Oral, labeled by Vortex Life Sciences, Inc.. 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 Vortex Life Sciences, Inc. on March 01, 2022. The current certification is valid through December 31, 2023.

How is this Vortex Life Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82529000101. 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)
82529-001-01
11-Digit CMS (5-4-2)
82529-0001-01

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