NDC 0404-9891 Lidocaine Hydrochloride And Epinephrine

Injection, Solution Infiltration - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0404-9891
Proprietary Name:
Lidocaine Hydrochloride And Epinephrine
Non-Proprietary Name: [1]
Lidocaine Hydrochloride And Epinephrine
Substance Name: [2]
Epinephrine; Lidocaine Hydrochloride
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]
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Labeler Name: [5]
    Henry Schein, Inc.
    Labeler Code:
    0404
    FDA Application Number: [6]
    ANDA089644
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-12-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0404-9891-20

    Package Description: 1 VIAL, MULTI-DOSE in 1 BAG / 30 mL in 1 VIAL, MULTI-DOSE

    NDC Code 0404-9891-30

    Package Description: 1 VIAL, MULTI-DOSE in 1 BAG / 20 mL in 1 VIAL, MULTI-DOSE

    NDC Code 0404-9891-50

    Package Description: 1 VIAL, MULTI-DOSE in 1 BAG / 50 mL in 1 VIAL, MULTI-DOSE

    Product Details

    What is NDC 0404-9891?

    The NDC code 0404-9891 is assigned by the FDA to the product Lidocaine Hydrochloride And Epinephrine which is a human prescription drug product labeled by Henry Schein, Inc.. The product's dosage form is injection, solution and is administered via infiltration form. The product is distributed in 3 packages with assigned NDC codes 0404-9891-20 1 vial, multi-dose in 1 bag / 30 ml in 1 vial, multi-dose, 0404-9891-30 1 vial, multi-dose in 1 bag / 20 ml in 1 vial, multi-dose, 0404-9891-50 1 vial, multi-dose in 1 bag / 50 ml in 1 vial, multi-dose. 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 Lidocaine Hydrochloride And Epinephrine?

    Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, 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 Lidocaine Hydrochloride And Epinephrine 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 10 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.
    • LIDOCAINE HYDROCHLORIDE 10 mg/mL - A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

    Which are Lidocaine Hydrochloride And Epinephrine UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Lidocaine Hydrochloride And Epinephrine?

    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: 1010751 - lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution
    • RxCUI: 1010751 - epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution
    • RxCUI: 1010751 - epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable Solution

    Which are the Pharmacologic Classes for Lidocaine Hydrochloride And Epinephrine?

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    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".