Isagel
NDC Package 11701-025-45

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

Isagel (alcohol) gel is wet hands thoroughly. This formulation utilizes a gel delivery system. Marketed by Coloplast Corp, this product is identified by NDC 11701-025 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
11701-025-45
Package Description
800 mL in 1 BAG
Product Code
11701-025
11-Digit Billing Format
11701002545
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
800 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isagel
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.
  • 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)
Usage Information
Wet hands thoroughly. Rub product into hands and allow to dry. Do not rinse. Wash hands with water and hand cleanser after every 7-9 applications. For use when hands are not visibly soiled.

Regulatory & Marketing

Labeler Name
Coloplast Corp
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-15-2009
End Marketing Date
11-30-2026
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 (11701-025). Click a package code to view its specific billing and regulatory data.

11701-025-04
118 mL in 1 BOTTLE
11701-025-26
621 mL in 1 BOTTLE

* 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 11701-025-45 identifies a specific commercial package of 800 ml in 1 bag of Isagel, a human over the counter drug labeled by Coloplast Corp. This product is billed per "ML" milliliter and contains an estimated amount of 800 billable units per package. This gel is formulated for topical use and contains alcohol 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 Coloplast Corp on June 15, 2009.

How is this Coloplast Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11701002545. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 800 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)
11701-025-45
11-Digit CMS (5-4-2)
11701-0025-45

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