Lidocaine Hcl And Epinephrine Injection
NDC Package 0264-9378-05

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

Package Information

Lidocaine Hcl And Epinephrine injection is lidocaine Hydrochloride and Epinephrine Injection is 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 delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-9378 and is authorized under FDA application ANDA208475.

Identification & Billing

NDC Package Code
0264-9378-05
Package Description
5 AMPULE in 1 CARTON / 5 mL in 1 AMPULE (0264-9378-88)
Product Code
0264-9378
11-Digit Billing Format
00264937805
RxNorm Crosswalk
  • RxCUI: 1867998 - lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML Injection
  • RxCUI: 1867998 - 5 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection
  • RxCUI: 1867998 - lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML Injection

Clinical Specifications

Proprietary Name
Lidocaine Hcl And Epinephrine
Non-Proprietary Name
Lidocaine Hcl And Epinephrine
Substance Name
Epinephrine Bitartrate; Lidocaine Hydrochloride Anhydrous
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intracaudal - Administration within the cauda equina.
  • Perineural - Administration surrounding a nerve or nerves.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Lidocaine Hydrochloride and Epinephrine Injection is 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
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208475
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2021
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 0264-9378-05 identifies a specific commercial package of 5 ampule in 1 carton / 5 ml in 1 ampule (0264-9378-88) of Lidocaine Hcl And Epinephrine, a human prescription drug labeled by B. Braun Medical Inc.. This injection is formulated for epidural; infiltration; intracaudal; 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 B. Braun Medical Inc. on September 08, 2021. The current certification is valid through December 31, 2026.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264937805. 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)
0264-9378-05
11-Digit CMS (5-4-2)
00264-9378-05

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