Maximum Strength Lidocaine Patch
NDC Package 76168-308-13

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.

Maximum Strength Lidocaine Patch is adults and children over 12 years:clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor. Marketed by Velocity Pharma Llc, this product is identified by NDC 76168-308 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
76168-308-13
Package Description
6 POUCH in 1 CARTON / 1 PATCH in 1 POUCH
Product Code
76168-308
11-Digit Billing Format
76168030813
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Maximum Strength Lidocaine Patch
Dosage Form
-
Usage Information
Adults and children over 12 years:clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor

Regulatory & Marketing

Labeler Name
Velocity Pharma Llc
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
05-26-2017
Listing Expiration
12-31-2019
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 76168-308-13 identifies a specific commercial package of 6 pouch in 1 carton / 1 patch in 1 pouch of Maximum Strength Lidocaine Patch, labeled by Velocity Pharma Llc. 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 Velocity Pharma Llc on May 26, 2017. The current certification is valid through December 31, 2019.

How is this Velocity Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76168030813. 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)
76168-308-13
11-Digit CMS (5-4-2)
76168-0308-13

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