Xylocaine Injection, Solution
NDC Package 0404-9975-50

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

Package Information

Xylocaine (lidocaine hydrochloride, epinephrine bitartrate injection, solution) injection is xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. This formulation utilizes a injection, solution delivery system. Marketed by Henry Schein, Inc, this product is identified by NDC 0404-9975 and is authorized under FDA application NDA006488.

Identification & Billing

NDC Package Code
0404-9975-50
Package Description
1 VIAL in 1 BAG / 50 mL in 1 VIAL
Product Code
0404-9975
11-Digit Billing Format
00404997550
RxNorm Crosswalk
  • RxCUI: 1010745 - lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution
  • RxCUI: 1010745 - epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution
  • RxCUI: 1010745 - epinephrine (as epinephrine bitartrate) 1:200,000 / lidocaine hydrochloride 0.5 % Injectable Solution
  • RxCUI: 1010749 - Xylocaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution
  • RxCUI: 1010749 - epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine with Epinephrine]

Clinical Specifications

Proprietary Name
Xylocaine
Non-Proprietary Name
Lidocaine Hydrochloride, Epinephrine Bitartrate Injection, Solution
Substance Name
Epinephrine Bitartrate; Lidocaine Hydrochloride Anhydrous
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Perineural - Administration surrounding a nerve or nerves.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA006488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-10-2022
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 0404-9975-50 identifies a specific commercial package of 1 vial in 1 bag / 50 ml in 1 vial of Xylocaine, a human prescription drug labeled by Henry Schein, Inc. This injection, solution is formulated for infiltration; perineural use and contains epinephrine bitartrate; lidocaine hydrochloride anhydrous 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 10, 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: 00404997550. 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)
0404-9975-50
11-Digit CMS (5-4-2)
00404-9975-50

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