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  5. NDC Package Code: 0362-0557-05 Marcaine

NDC Package 0362-0557-05 Marcaine

Bupivacaine Hydrochloride And Epinephrine Bitartrate 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:
0362-0557-05
Package Description:
50 CARTRIDGE in 1 CARTON / 1.8 mL in 1 CARTRIDGE
Product Code:
0362-0557
Proprietary Name:
Marcaine
Non-Proprietary Name:
Bupivacaine Hydrochloride And Epinephrine Bitartrate
Substance Name:
Bupivacaine Hydrochloride Anhydrous; Epinephrine Bitartrate
Usage Information:
Marcaine® 0.5% with epineprhine 1:200,000 is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults.Marcaine® 0.5% with epinephrine 1:200,000 is not recommended for children.
11-Digit NDC Billing Format:
00362055705
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1670365 - BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge
  • RxCUI: 1670365 - 1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge
  • RxCUI: 1670365 - bupivacaine HCl 0.5 % / epinephrine 1:200,000 per 1.8 ML Dental Cartridge
  • RxCUI: 1673142 - Marcaine 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge
  • RxCUI: 1673142 - 1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Marcaine with Epinephrine]
    • 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):
  • BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL
  • EPINEPHRINE BITARTRATE .005 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:
    ANDA077250
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-12-2018
    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 0362-0557-05?

    The NDC Packaged Code 0362-0557-05 is assigned to a package of 50 cartridge in 1 carton / 1.8 ml in 1 cartridge of Marcaine, a human prescription drug labeled by Septodont, Inc.. The product's dosage form is injection, solution and is administered via submucosal form.

    Is NDC 0362-0557 included in the NDC Directory?

    Yes, Marcaine with product code 0362-0557 is active and included in the NDC Directory. The product was first marketed by Septodont, Inc. on June 12, 2018 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 NDC billing unit for package 0362-0557-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0362-0557-05?

    The 11-digit format is 00362055705. 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
    4-4-20362-0557-055-4-200362-0557-05