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  5. NDC Package Code: 45146-110-01 Orabloc

NDC Package 45146-110-01 Orabloc

Articaine Hydrochloride And Epinephrine Bitartrate Injection Submucosal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
45146-110-01
Package Description:
100 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE
Product Code:
45146-110
Proprietary Name:
Orabloc
Non-Proprietary Name:
Articaine Hydrochloride And Epinephrine Bitartrate
Substance Name:
Articaine Hydrochloride; Epinephrine Bitartrate
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.
11-Digit NDC Billing Format:
45146011001
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pierrel S.p.a.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Submucosal - Administration beneath the mucous membrane.
    • Active Ingredient(s):
  • ARTICAINE HYDROCHLORIDE 40 mg/mL
  • EPINEPHRINE BITARTRATE 10 ug/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Catecholamine - [EPC] (Established Pharmacologic Class)
  • Catecholamines - [CS]
  • Local Anesthesia - [PE] (Physiologic Effect)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA022466
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-01-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    45146-110-0250 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45146-110-01?

    The NDC Packaged Code 45146-110-01 is assigned to a 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.. The product's dosage form is injection and is administered via submucosal form.

    Is NDC 45146-110 included in the NDC Directory?

    Yes, Orabloc with product code 45146-110 is active and included in the NDC Directory. The product was first marketed by Pierrel S.p.a. on March 01, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 45146-110-01?

    The 11-digit format is 45146011001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245146-110-015-4-245146-0110-01