1. Home
  2. Labeler Index
  3. Septodont, Inc.
  4. 0362-1095
  5. NDC Package Code: 0362-1095-60 Lignospan Standard

NDC Package 0362-1095-60 Lignospan Standard

Lidocaine 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:
0362-1095-60
Package Description:
5 BLISTER PACK in 1 CARTON / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE
Product Code:
0362-1095
Proprietary Name:
Lignospan Standard
Non-Proprietary Name:
Lidocaine Hydrochloride And Epinephrine
Substance Name:
Epinephrine Bitartrate; Lidocaine Hydrochloride
Usage Information:
LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.Only accepted procedures for these techniques as described in standard textbooks are recommended.
11-Digit NDC Billing Format:
00362109560
NDC to RxNorm Crosswalk:
  • RxCUI: 1011809 - Lignospan standard 2 % / 1:100,000 in 1.7 mL Dental Cartridge
  • RxCUI: 1011809 - 1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge [Lignospan]
  • RxCUI: 1011809 - Lignospan standard 2 % / 1:100,000 1.7 ML Dental Cartridge
  • RxCUI: 1293648 - lidocaine HCl 2 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge
  • RxCUI: 1293648 - 1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML 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):
  • EPINEPHRINE BITARTRATE .01 mg/mL
  • LIDOCAINE HYDROCHLORIDE 20 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]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • 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:
    ANDA088390
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-28-2017
    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 0362-1095-60?

    The NDC Packaged Code 0362-1095-60 is assigned to a package of 5 blister pack in 1 carton / 10 cartridge in 1 blister pack / 1.7 ml in 1 cartridge of Lignospan Standard, a human prescription drug labeled by Septodont, Inc.. The product's dosage form is injection, solution and is administered via submucosal form.

    Is NDC 0362-1095 included in the NDC Directory?

    Yes, Lignospan Standard with product code 0362-1095 is active and included in the NDC Directory. The product was first marketed by Septodont, Inc. on November 28, 2017 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 0362-1095-60?

    The 11-digit format is 00362109560. 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
    4-4-20362-1095-605-4-200362-1095-60