Hygel
NDC Package 15014-105-40

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 discontinued by the firm.

Hygel is ™ is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically or surgically debrided wounds, and for second degree burns.HyGel™ is indicated for the management and relief of burning, itching, and pain associated with various types of dermatoses; including atopic dermatitis, allergic contract dermatitis and radio-dermatitis. Marketed by Gentex Pharma, Llc, this product is identified by NDC 15014-105.

Identification & Billing

NDC Package Code
15014-105-40
Package Description
4 TUBE in 1 CARTON / 10 g in 1 TUBE (15014-105-10)
Product Code
15014-105
11-Digit Billing Format
15014010540
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
10 GM

Clinical Specifications

Proprietary Name
Hygel
Dosage Form
-
Usage Information
HyGel™ is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically or surgically debrided wounds, and for second degree burns.HyGel™ is indicated for the management and relief of burning, itching, and pain associated with various types of dermatoses; including atopic dermatitis, allergic contract dermatitis and radio-dermatitis.

Regulatory & Marketing

Labeler Name
Gentex Pharma, Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
10-15-2015
End Marketing Date
07-01-2016
Listing Expiration
07-01-2016
Exclude Flag
D
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 15014-105-40 identifies a specific commercial package of 4 tube in 1 carton / 10 g in 1 tube (15014-105-10) of Hygel, labeled by Gentex Pharma, Llc. This product is billed per "GM" gram and contains an estimated amount of 10 billable units per package. 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 Gentex Pharma, Llc on October 15, 2015. The current certification is valid through July 01, 2016.

How is this Gentex Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15014010540. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 10 total billable units per package. 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)
15014-105-40
11-Digit CMS (5-4-2)
15014-0105-40

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