Orabloc Injection
NDC Package 45146-110-01

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

Package Information

Orabloc (articaine hydrochloride and epinephrine bitartrate) injection is orabloc® is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. This formulation utilizes a injection delivery system. Marketed by Pierrel S.p.a., this product is identified by NDC 45146-110 and is authorized under FDA application NDA022466.

Identification & Billing

NDC Package Code
45146-110-01
Package Description
100 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE
Product Code
45146-110
11-Digit Billing Format
45146011001
RxNorm Crosswalk
  • RxCUI: 1091068 - Orabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge
  • RxCUI: 1091068 - 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]
  • RxCUI: 1091072 - Orabloc 4 % / 1:200,000 in 1.8 mL Dental Cartridge
  • RxCUI: 1091072 - 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Orabloc]
  • RxCUI: 1091072 - Orabloc 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.8 ML Cartridge

Clinical Specifications

Proprietary Name
Orabloc
Non-Proprietary Name
Articaine Hydrochloride And Epinephrine Bitartrate
Substance Name
Articaine Hydrochloride; Epinephrine Bitartrate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Submucosal - Administration beneath the mucous membrane.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Orabloc® is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

Regulatory & Marketing

Labeler Name
Pierrel S.p.a.
Product Type
Human Prescription Drug
FDA Application #
NDA022466
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45146-110). Click a package code to view its specific billing and regulatory data.

45146-110-02
50 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE

* 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 45146-110-01 identifies a specific commercial package of 100 cartridge in 1 box / 1.8 ml in 1 cartridge of Orabloc, a human prescription drug labeled by Pierrel S.p.a.. This injection 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 Pierrel S.p.a. on March 01, 2011. The current certification is valid through December 31, 2026.

How is this Pierrel S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45146011001. 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)
45146-110-01
11-Digit CMS (5-4-2)
45146-0110-01

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