4% Lidocaine Patch
NDC Package 65604-101-40

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

4% Lidocaine Patch patches is a medication used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). This formulation utilizes a patch delivery system. Marketed by Akron Coating & Adhesives, this product is identified by NDC 65604-101.

Identification & Billing

NDC Package Code
65604-101-40
Package Description
2.33 mg in 1 CELLO PACK
Product Code
65604-101
11-Digit Billing Format
65604010140

Clinical Specifications

Proprietary Name
4% Lidocaine Patch
Non-Proprietary Name
4% Lidocaine Patch
Substance Name
Lidocaine
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Active Ingredient(s)
LIDOCAINE 4 mg/100mg
Usage Information
This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

Regulatory & Marketing

Labeler Name
Akron Coating & Adhesives
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65604-101-40 identifies a specific commercial package of 2.33 mg in 1 cello pack of 4% Lidocaine Patch (UNFINISHED drug), drug for further processing labeled by Akron Coating & Adhesives. This patch is formulated for use and contains lidocaine 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 Akron Coating & Adhesives on August 01, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

How is this Akron Coating & Adhesives product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65604010140. 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)
65604-101-40
11-Digit CMS (5-4-2)
65604-0101-40

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