Lidocaine Hydrochloride
NDC Package 52565-009-50

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.

Lidocaine Hydrochloride is topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Marketed by Teligent Pharma, Inc., this product is identified by NDC 52565-009 and is authorized under FDA application ANDA204494.

Identification & Billing

NDC Package Code
52565-009-50
Package Description
1 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS
Product Code
52565-009
11-Digit Billing Format
52565000950
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1010878 - lidocaine HCl 4 % Mucous Membrane Topical Solution
  • RxCUI: 1010878 - lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical Solution
  • RxCUI: 1010878 - lidocaine hydrochloride 4 % Mucous Membrane Topical Solution
  • RxCUI: 1010878 - lidocaine hydrochloride 4 % Oromucosal Solution

Clinical Specifications

Proprietary Name
Lidocaine Hydrochloride
Dosage Form
-
Usage Information
Lidocaine Hydrochloride Topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.

Regulatory & Marketing

Labeler Name
Teligent Pharma, Inc.
FDA Application #
ANDA204494
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2014
Listing Expiration
12-31-2022
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 52565-009-50 identifies a specific commercial package of 1 bottle, glass in 1 carton / 50 ml in 1 bottle, glass of Lidocaine Hydrochloride, labeled by Teligent Pharma, 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 Teligent Pharma, Inc. on March 18, 2014. The current certification is valid through December 31, 2022.

How is this Teligent Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52565000950. 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 (5-3-2)
52565-009-50
11-Digit CMS (5-4-2)
52565-0009-50

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