Lidocaine
NDC Package 0517-0625-25

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 discontinued by the firm.

Lidocaine is a medication used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). Marketed by American Regent, Inc., this product is identified by NDC 0517-0625 and is authorized under FDA application ANDA080850.

Identification & Billing

NDC Package Code
0517-0625-25
Package Description
25 VIAL, MULTI-DOSE in 1 BOX / 50 mL in 1 VIAL, MULTI-DOSE
Product Code
0517-0625
11-Digit Billing Format
00517062525
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Lidocaine
Dosage Form
-
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
American Regent, Inc.
FDA Application #
ANDA080850
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2006
End Marketing Date
09-01-2012
Listing Expiration
09-01-2012
Exclude Flag
D
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 0517-0625-25 identifies a specific commercial package of 25 vial, multi-dose in 1 box / 50 ml in 1 vial, multi-dose of Lidocaine, labeled by American Regent, Inc.. 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 American Regent, Inc. on June 01, 2006. The current certification is valid through September 01, 2012.

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 American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517062525. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0517-0625-25
11-Digit CMS (5-4-2)
00517-0625-25

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