Hydraphex Solution
NDC Package 78003-140-80

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

Package Information

Hydraphex solution is a medication used as Active ingredients: Benzalkonium Chloride 0.11% - 0 .13% (As sanitizing agent). This formulation utilizes a solution delivery system. Marketed by Aphex Biocleanse Systems, Inc, this product is identified by NDC 78003-140 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78003-140-80
Package Description
1045000 mL in 1 CONTAINER
Product Code
78003-140
11-Digit Billing Format
78003014080

Clinical Specifications

Proprietary Name
Hydraphex
Non-Proprietary Name
Hydraphex
Substance Name
Benzalkonium Chloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
BENZALKONIUM CHLORIDE .0013 g/mL
Usage Information
This product is used as Active ingredients: Benzalkonium Chloride 0.11% - 0 .13% (As sanitizing agent)

Regulatory & Marketing

Labeler Name
Aphex Biocleanse Systems, Inc
Product Type
Human Otc Drug
FDA Application #
part333A
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
06-01-2012
End Marketing Date
01-31-2029
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78003-140). Click a package code to view its specific billing and regulatory data.

78003-140-70
208000 mL in 1 DRUM

* 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 78003-140-80 identifies a specific commercial package of 1045000 ml in 1 container of Hydraphex, a human over the counter drug labeled by Aphex Biocleanse Systems, Inc. This solution is formulated for topical use and contains benzalkonium chloride 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 Aphex Biocleanse Systems, Inc on June 01, 2012.

How is this Aphex Biocleanse Systems, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78003014080. 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)
78003-140-80
11-Digit CMS (5-4-2)
78003-0140-80

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