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  5. NDC Package Code: 0362-0830-05 Zorcaine

NDC Package 0362-0830-05 Zorcaine

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

Table of Contents

    1. Package Information
    2. 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:
0362-0830-05
Package Description:
50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE
Product Code:
0362-0830
Proprietary Name:
Zorcaine
Non-Proprietary Name:
Articaine Hydrochloride And Epinephrine
Substance Name:
Articaine Hydrochloride; Epinephrine Bitartrate
Usage Information:
Zorcaine® 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.
11-Digit NDC Billing Format:
00362083005
NDC to RxNorm Crosswalk:
  • RxCUI: 1595035 - articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge
  • RxCUI: 1595035 - 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge
  • RxCUI: 1595035 - articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental Cartridge
  • RxCUI: 1595035 - articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental Cartridge
  • RxCUI: 861592 - Zorcaine 4 % / 1:100,000 in 1.7 mL Dental Cartridge
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Septodont, Inc.
    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(s):
  • Submucosal - Administration beneath the mucous membrane.
    • Active Ingredient(s):
  • ARTICAINE HYDROCHLORIDE 40 mg/mL
  • EPINEPHRINE BITARTRATE .01 mg/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:
    NDA020971
    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:
    04-05-2019
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 0362-0830-05?

    The NDC Packaged Code 0362-0830-05 is assigned to a package of 50 cartridge in 1 carton / 1.7 ml in 1 cartridge of Zorcaine, a human prescription drug labeled by Septodont, Inc.. The product's dosage form is injection, solution and is administered via submucosal form.

    Is NDC 0362-0830 included in the NDC Directory?

    Yes, Zorcaine with product code 0362-0830 is active and included in the NDC Directory. The product was first marketed by Septodont, Inc. on April 05, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0362-0830-05?

    The 11-digit format is 00362083005. 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 4-4-2 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
    4-4-20362-0830-055-4-200362-0830-05