Lidocaine Hydrochloride Solution
NDC Package 10135-736-51

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

Package Information

Lidocaine Hydrochloride solution is lidocaine hydrochloride 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. This formulation utilizes a solution delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-736 and is authorized under FDA application ANDA216250.

Identification & Billing

NDC Package Code
10135-736-51
Package Description
1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE
Product Code
10135-736
11-Digit Billing Format
10135073651
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
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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 40 mg/mL
Pharmacologic Class
Usage Information
Lidocaine hydrochloride 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
Marlex Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216250
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2022
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 10135-736-51 identifies a specific commercial package of 1 bottle in 1 carton / 50 ml in 1 bottle of Lidocaine Hydrochloride, a human prescription drug labeled by Marlex Pharmaceuticals, Inc.. This solution 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 Marlex Pharmaceuticals, Inc. on June 01, 2022. The current certification is valid through December 31, 2026.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135073651. 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)
10135-736-51
11-Digit CMS (5-4-2)
10135-0736-51

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