Lidocaine Hydrochloride Jelly
NDC Package 0404-9899-20

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

Package Information

Lidocaine Hydrochloride jellies is lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). This formulation utilizes a jelly delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9899 and is authorized under FDA application ANDA086283.

Identification & Billing

NDC Package Code
0404-9899-20
Package Description
1 VIAL, SINGLE-USE in 1 BAG / 20 mL in 1 VIAL, SINGLE-USE
Product Code
0404-9899
11-Digit Billing Format
00404989920
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lidocaine Hydrochloride
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
Dosage Form
Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.
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 20 mg/mL
Pharmacologic Class
Usage Information
Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA086283
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-12-2022
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 0404-9899-20 identifies a specific commercial package of 1 vial, single-use in 1 bag / 20 ml in 1 vial, single-use of Lidocaine Hydrochloride, a human prescription drug labeled by Henry Schein, Inc.. This jelly 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 Henry Schein, Inc. on January 12, 2022. The current certification is valid through December 31, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404989920. 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)
0404-9899-20
11-Digit CMS (5-4-2)
00404-9899-20

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