NDC 45146-120 Orabloc

Articaine Hydrochloride And Epinephrine Bitartrate Injection Submucosal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
45146-120
Proprietary Name:
Orabloc
Non-Proprietary Name: [1]
Articaine Hydrochloride And Epinephrine Bitartrate
Substance Name: [2]
Articaine Hydrochloride; Epinephrine Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Submucosal - Administration beneath the mucous membrane.
  • Labeler Name: [5]
    Pierrel S.p.a.
    Labeler Code:
    45146
    FDA Application Number: [6]
    NDA022466
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-01-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 45146-120-01

    Package Description: 100 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE

    NDC Code 45146-120-02

    Package Description: 50 CARTRIDGE in 1 BOX / 1.8 mL in 1 CARTRIDGE

    Product Details

    What is NDC 45146-120?

    The NDC code 45146-120 is assigned by the FDA to the product Orabloc which is a human prescription drug product labeled by Pierrel S.p.a.. The generic name of Orabloc is articaine hydrochloride and epinephrine bitartrate. The product's dosage form is injection and is administered via submucosal form. The product is distributed in 2 packages with assigned NDC codes 45146-120-01 100 cartridge in 1 box / 1.8 ml in 1 cartridge, 45146-120-02 50 cartridge in 1 box / 1.8 ml in 1 cartridge. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Orabloc?

    Orabloc® is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

    What are Orabloc Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ARTICAINE HYDROCHLORIDE 40 mg/mL
    • EPINEPHRINE BITARTRATE 5 ug/mL - The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS.

    Which are Orabloc UNII Codes?

    The UNII codes for the active ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Orabloc?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".