Sirenol Antiseptic Topical
NDC Package 80441-002-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sirenol Antiseptic Topical is place enough product on hands to cover all surfaces. Marketed by Bm Global Elektronik Gida Sanayi Ve Dis Ticaret Limited Sirketi, this product is identified by NDC 80441-002 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
80441-002-08
Package Description
1000 mL in 1 BOTTLE
Product Code
11-Digit Billing Format
80441000208
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sirenol Antiseptic Topical
Dosage Form
-
Usage Information
Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Bm Global Elektronik Gida Sanayi Ve Dis Ticaret Limited Sirketi
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
09-02-2020
Listing Expiration
12-31-2021
Exclude Flag
I
Sample Package
No

Hierarchy Structure

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 (80441-002). Click a package code to view its specific billing and regulatory data.

25 mL in 1 BOTTLE
50 mL in 1 BOTTLE
100 mL in 1 BOTTLE
150 mL in 1 BOTTLE
200 mL in 1 BOTTLE
250 mL in 1 BOTTLE
500 mL in 1 BOTTLE
3785 mL in 1 BOTTLE
5000 mL in 1 BOTTLE
10000 mL in 1 BOTTLE
6 NOT APPLICABLE in 1 PACKAGE / 5 mL in 1 NOT APPLICABLE
10 NOT APPLICABLE in 1 PACKAGE / 5 mL in 1 NOT APPLICABLE
20 NOT APPLICABLE in 1 PACKAGE / 5 mL in 1 NOT APPLICABLE
100 NOT APPLICABLE in 1 PACKAGE / 5 mL in 1 NOT APPLICABLE
1000 NOT APPLICABLE in 1 PACKAGE / 5 mL in 1 NOT APPLICABLE

* 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 80441-002-08 identifies a specific commercial package of 1000 ml in 1 bottle of Sirenol Antiseptic Topical, labeled by Bm Global Elektronik Gida Sanayi Ve Dis Ticaret Limited Sirketi. 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 Bm Global Elektronik Gida Sanayi Ve Dis Ticaret Limited Sirketi on September 02, 2020. The current certification is valid through December 31, 2021.

How is this Bm Global Elektronik Gida Sanayi Ve Dis Ticaret Limited Sirketi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80441000208. 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)
80441-002-08
11-Digit CMS (5-4-2)
80441-0002-08

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