Fiberlay Ethanol Disposable Gel Disinfectant
NDC Package 53048-001-01

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.

Fiberlay Ethanol Disposable Gel Disinfectant is 1.Hygiene hands: Take an aprpiate amount of hand dsinfectant on the palm of your hands, rub your hands together for 1 minute to dsinfect. Marketed by Shandong Lugangfuyou Medical Co., Ltd, this product is identified by NDC 53048-001 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
53048-001-01
Package Description
500 mL in 1 BOTTLE
Product Code
53048-001
11-Digit Billing Format
53048000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fiberlay Ethanol Disposable Gel Disinfectant
Dosage Form
-
Usage Information
1.Hygiene hands: Take an aprpiate amount of hand dsinfectant on the palm of your hands, rub your hands together for 1 minute to dsinfect. 2. Surgical hands: After surgical hand washing take an apropiate amount of hand dsinfecant and evenly apply it to the skin of the hands, forearm and lower third of the upper arm for 3min. 3. Skin: Apply the skin surface evenly for 3min.

Regulatory & Marketing

Labeler Name
Shandong Lugangfuyou Medical Co., Ltd
FDA Application #
part333E
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
05-22-2020
Listing Expiration
12-31-2021
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 53048-001-01 identifies a specific commercial package of 500 ml in 1 bottle of Fiberlay Ethanol Disposable Gel Disinfectant, labeled by Shandong Lugangfuyou Medical 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 Shandong Lugangfuyou Medical Co., Ltd on May 22, 2020. The current certification is valid through December 31, 2021.

How is this Shandong Lugangfuyou Medical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53048000101. 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)
53048-001-01
11-Digit CMS (5-4-2)
53048-0001-01

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