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  5. NDC Package Code: 66312-580-16 Citanest Forte Dental

NDC Package 66312-580-16 Citanest Forte Dental

Prilocaine Hcl 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:
66312-580-16
Package Description:
50 CARTRIDGE in 1 CARTON / 1.8 mL in 1 CARTRIDGE
Product Code:
66312-580
Proprietary Name:
Citanest Forte Dental
Non-Proprietary Name:
Prilocaine Hcl And Epinephrine
Substance Name:
Epinephrine Bitartrate; Prilocaine Hydrochloride
Usage Information:
Citanest Forte is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
11-Digit NDC Billing Format:
66312058016
NDC to RxNorm Crosswalk:
  • RxCUI: 1596950 - prilocaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 ML Cartridge
  • RxCUI: 1596950 - 1.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML Cartridge
  • RxCUI: 1596950 - epinephrine 1:200,000 / prilocaine HCl 4 % 1.8 ML Cartridge
  • RxCUI: 1596950 - prilocaine HCl 4 % / epinephrine (as epinephrine bitartrate) 1:200,000 in 1.8 ML Cartridge
  • RxCUI: 1993224 - Citanest Forte 4 % / 1:200,000 in 1.8 ML Cartridge
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dentsply Pharmaceutical 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 .005 mg/mL
  • PRILOCAINE HYDROCHLORIDE 40 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:
    ANDA078959
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-04-2017
    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 66312-580-16?

    The NDC Packaged Code 66312-580-16 is assigned to a package of 50 cartridge in 1 carton / 1.8 ml in 1 cartridge of Citanest Forte Dental, a human prescription drug labeled by Dentsply Pharmaceutical Inc.. The product's dosage form is injection, solution and is administered via submucosal form.

    Is NDC 66312-580 included in the NDC Directory?

    Yes, Citanest Forte Dental with product code 66312-580 is active and included in the NDC Directory. The product was first marketed by Dentsply Pharmaceutical Inc. on December 04, 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 66312-580-16?

    The 11-digit format is 66312058016. 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
    5-3-266312-580-165-4-266312-0580-16