Flex24 Pain Pen
NDC Package 54641-003-02

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.

Flex24 Pain Pen is adults and children over the age of 12:• Remove plastic top from device and put aside till after treatment• Apply liniment to affected area• Repeat as necessary but no more than 3 treatments per day• Children under 12, consult a doctor before use. Marketed by Larasan Pharmaceutical Corporation, this product is identified by NDC 54641-003 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
54641-003-02
Package Description
18 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
54641-003
11-Digit Billing Format
54641000302
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
18 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flex24 Pain Pen
Dosage Form
-
Usage Information
Adults and children over the age of 12:• Remove plastic top from device and put aside till after treatment• Apply liniment to affected area• Repeat as necessary but no more than 3 treatments per day• Children under 12, consult a doctor before use.

Regulatory & Marketing

Labeler Name
Larasan Pharmaceutical Corporation
FDA Application #
part348
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
02-10-2015
Listing Expiration
12-31-2020
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 54641-003-02 identifies a specific commercial package of 18 ml in 1 bottle, with applicator of Flex24 Pain Pen, labeled by Larasan Pharmaceutical Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 18 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 Larasan Pharmaceutical Corporation on February 10, 2015. The current certification is valid through December 31, 2020.

How is this Larasan Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54641000302. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 18 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)
54641-003-02
11-Digit CMS (5-4-2)
54641-0003-02

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