Articaine Hydrochloride And Epinephrine Injection, Solution
NDC Package 43498-993-01

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

Package Information

Articaine Hydrochloride And Epinephrine (articaine hydrochloride, epinephrine bitartrate) injection is articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. This formulation utilizes a injection, solution delivery system. Marketed by Burkhart Dental Supply Co., Inc, this product is identified by NDC 43498-993 and is authorized under FDA application NDA022466.

Identification & Billing

NDC Package Code
43498-993-01
Package Description
50 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE
Product Code
43498-993
11-Digit Billing Format
43498099301
RxNorm Crosswalk
  • RxCUI: 1658966 - articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental Cartridge
  • RxCUI: 1658966 - 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge
  • RxCUI: 1658966 - articaine HCl 4 % / epinephrine 1:200,000 1.8 ML Cartridge
  • RxCUI: 1661483 - articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
  • RxCUI: 1661483 - 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge

Clinical Specifications

Proprietary Name
Articaine Hydrochloride And Epinephrine
Non-Proprietary Name
Articaine Hydrochloride, Epinephrine Bitartrate
Substance Name
Articaine Hydrochloride; Epinephrine Bitartrate
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
Submucosal - Administration beneath the mucous membrane.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.

Regulatory & Marketing

Labeler Name
Burkhart Dental Supply Co., Inc
Product Type
Human Prescription Drug
FDA Application #
NDA022466
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-04-2024
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 43498-993-01 identifies a specific commercial package of 50 cartridge in 1 box / 1.8 ml in 1 cartridge of Articaine Hydrochloride And Epinephrine, a human prescription drug labeled by Burkhart Dental Supply Co., Inc. This injection, solution is formulated for submucosal use and contains articaine hydrochloride; epinephrine bitartrate 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 Burkhart Dental Supply Co., Inc on November 04, 2024. The current certification is valid through December 31, 2026.

How is this Burkhart Dental Supply Co., Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43498099301. 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 (5-3-2)
43498-993-01
11-Digit CMS (5-4-2)
43498-0993-01

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