NDC 52584-489 Xylocaine

Lidocaine Hydrochloride And Epinephrine Injection, Solution Epidural; Infiltration; - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
52584-489
Proprietary Name:
Xylocaine
Non-Proprietary Name: [1]
Lidocaine Hydrochloride And Epinephrine
Substance Name: [2]
Epinephrine Bitartrate; Lidocaine Hydrochloride Anhydrous
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intracaudal - Administration within the cauda equina.
  • Perineural - Administration surrounding a nerve or nerves.
  • Labeler Name: [5]
    General Injectables & Vaccines, Inc
    Labeler Code:
    52584
    FDA Application Number: [6]
    NDA006488
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-27-2011
    End Marketing Date: [10]
    03-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 52584-489-27

    Package Description: 1 VIAL in 1 BAG / 20 mL in 1 VIAL

    Product Details

    What is NDC 52584-489?

    The NDC code 52584-489 is assigned by the FDA to the product Xylocaine which is a human prescription drug product labeled by General Injectables & Vaccines, Inc. The generic name of Xylocaine is lidocaine hydrochloride and epinephrine. The product's dosage form is injection, solution and is administered via epidural; infiltration; intracaudal; perineural form. The product is distributed in a single package with assigned NDC code 52584-489-27 1 vial in 1 bag / 20 ml in 1 vial. 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 Xylocaine?

    Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

    What are Xylocaine 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.
    • EPINEPHRINE BITARTRATE .005 mg/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.
    • LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL

    Which are Xylocaine UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Xylocaine?

    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: 1010688 - lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML Injection
    • RxCUI: 1010688 - 20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection
    • RxCUI: 1010688 - lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML Injection
    • RxCUI: 1010692 - Xylocaine 2 % / EPINEPHrine 1:200,000 in 20 ML Injection
    • RxCUI: 1010692 - 20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]

    * 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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".