Hydrogel Essence Antimicrobial Virginal Gel.
NDC Package 84642-001-01

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.

Hydrogel Essence Antimicrobial Virginal Gel. is aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Marketed by Guangdong Amoreneg Medicine Research And Development Co., Ltd, this product is identified by NDC 84642-001.

Identification & Billing

NDC Package Code
84642-001-01
Package Description
3.5 g in 1 TUBE
Product Code
84642-001
11-Digit Billing Format
84642000101

Clinical Specifications

Proprietary Name
Hydrogel Essence Antimicrobial Virginal Gel.
Dosage Form
-
Usage Information
Aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Lie flat on your back. Gently insert the applicator into the vagina and push the hydrogel inside. Remain lying still for 2 minutes to allow the hydrogel to set and transition from liquid to gel format at body temperature.Children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Guangdong Amoreneg Medicine Research And Development Co., Ltd
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-15-2024
Listing Expiration
12-31-2025
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 84642-001-01 identifies a specific commercial package of 3.5 g in 1 tube of Hydrogel Essence Antimicrobial Virginal Gel., labeled by Guangdong Amoreneg Medicine Research And Development Co., Ltd. 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 Guangdong Amoreneg Medicine Research And Development Co., Ltd on August 15, 2024. The current certification is valid through December 31, 2025.

How is this Guangdong Amoreneg Medicine Research And Development Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84642000101. 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)
84642-001-01
11-Digit CMS (5-4-2)
84642-0001-01

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