Vial Kit3.98
NDC Package 80851-302-01

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.

Vial Kit3.98 is [Preparation stage]After cleansing, use toner to clean up the skin.It must be used only after cleansing is complete, and especially pay attention to the cleanliness of your hands.If you use it after exfoliation, you can get more satisfactory results, and it is more effective if you give a simple massage before use.[Application stage]1. Marketed by Oxytical, this product is identified by NDC 80851-302.

Identification & Billing

NDC Package Code
80851-302-01
Package Description
.02 mL in 1 BOTTLE, GLASS
Product Code
80851-302
11-Digit Billing Format
80851030201

Clinical Specifications

Proprietary Name
Vial Kit3.98
Dosage Form
-
Usage Information
[Preparation stage]After cleansing, use toner to clean up the skin.It must be used only after cleansing is complete, and especially pay attention to the cleanliness of your hands.If you use it after exfoliation, you can get more satisfactory results, and it is more effective if you give a simple massage before use.[Application stage]1. Prepare Core peptide(1st), Stable Chitin(2nd) and a syringe.2. Core Peptide(1st) only opens the plastic cap.3. A syringe inlet is injected into the center of the hole at the top of the Core Peptide(1st) to suction. (Total 3ml based on syringe).After the syringe is removed, the inlet is automatically sealed to prevent outside air from entering.4. Open the Stable Chitin(2nd) after referring to the precautions and inject the Core Peptide(1st).Due to the nature of the Stable Chitin component, it is not soluble in ampoule other than Core Peptide. (Not compatible)5. Close the vial opening of the Stable Chitin(2nd) with an elastomer tube and shake to dissolve the Stable Chitin.Check with eyes and if the Stable Chitin component does not appear in the form of a thread (slightly thick), apply it to the skin.

Regulatory & Marketing

Labeler Name
Oxytical
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-12-2020
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 80851-302-01 identifies a specific commercial package of .02 ml in 1 bottle, glass of Vial Kit3.98, labeled by Oxytical. 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 Oxytical on November 12, 2020. The current certification is valid through December 31, 2023.

How is this Oxytical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80851030201. 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)
80851-302-01
11-Digit CMS (5-4-2)
80851-0302-01

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