Lidocaine Hydrochloride Solution
NDC Package 0116-4027-40

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

Package Information

Lidocaine Hydrochloride solution is lidocaine Hydrochloride Oral Topical Solution, USP 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. This formulation utilizes a solution delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-4027 and is authorized under FDA application ANDA087872.

Identification & Billing

NDC Package Code
0116-4027-40
Package Description
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4027-15)
Product Code
0116-4027
11-Digit Billing Format
00116402740
RxNorm Crosswalk

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
  • Oral - Administration to or by way of the mouth.
  • 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 20 mg/mL
Pharmacologic Class
Usage Information
Lidocaine Hydrochloride Oral Topical Solution, USP 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA087872
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0116-4027). Click a package code to view its specific billing and regulatory data.

0116-4027-10
100 mL in 1 BOTTLE, PLASTIC

* 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 0116-4027-40 identifies a specific commercial package of 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose (0116-4027-15) of Lidocaine Hydrochloride, a human prescription drug labeled by Xttrium Laboratories, Inc.. This solution is formulated for oral; 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 Xttrium Laboratories, Inc. on March 28, 2023. The current certification is valid through December 31, 2027.

How is this Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116402740. 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)
0116-4027-40
11-Digit CMS (5-4-2)
00116-4027-40

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