Lidotral 5 Percent Roll On Gel
NDC Package 59088-327-07

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

Package Information

Lidotral 5 Percent Roll On Gel (lidocaine hydrochloride) gel is for the temporary relief of arthritis pain ONLY in the following areas:hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas)this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. This formulation utilizes a gel delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-327.

Identification & Billing

NDC Package Code
59088-327-07
Package Description
85 g in 1 BOTTLE, WITH APPLICATOR
Product Code
59088-327
11-Digit Billing Format
59088032707
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
85 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lidotral 5 Percent Roll On Gel
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
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.
Active Ingredient(s)
LIDOCAINE HYDROCHLORIDE 50 mg/g
Pharmacologic Class
Usage Information
For the temporary relief of arthritis pain ONLY in the following areas:hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas)this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use. For the temporary relief of pain.

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-02-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59088-327-07 identifies a specific commercial package of 85 g in 1 bottle, with applicator of Lidotral 5 Percent Roll On Gel, a human prescription drug labeled by Puretek Corporation. This product is billed per "GM" gram and contains an estimated amount of 85 billable units per package. This gel is formulated for topical use and contains lidocaine hydrochloride 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 Puretek Corporation on August 02, 2024. The current certification is valid through December 31, 2026.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088032707. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 85 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)
59088-327-07
11-Digit CMS (5-4-2)
59088-0327-07

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