Lidocaine Hydrochloride Solution
NDC Package 70518-4030-0

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 Oral Topical Solution 2% (Viscous) 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 Remedyrepack Inc., this product is identified by NDC 70518-4030 and is authorized under FDA application ANDA216780.

Identification & Billing

NDC Package Code
70518-4030-0
Package Description
100 mL in 1 BOTTLE
Product Code
70518-4030
11-Digit Billing Format
70518403000
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 2% (Viscous) 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216780
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-29-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4030-0 identifies a specific commercial package of 100 ml in 1 bottle of Lidocaine Hydrochloride, a human prescription drug labeled by Remedyrepack 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 Remedyrepack Inc. on February 29, 2024. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518403000. 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 (5-4-1)
70518-4030-0
11-Digit CMS (5-4-2)
70518-4030-00

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