NDC 0409-9045 Bupivacaine Hydrochloride And Epinephrine

Injection, Solution Epidural; Intracaudal; Perineural - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0409-9045
Proprietary Name:
Bupivacaine Hydrochloride And Epinephrine
Non-Proprietary Name: [1]
Bupivacaine Hydrochloride And Epinephrine
Substance Name: [2]
Bupivacaine Hydrochloride; Epinephrine Bitartrate
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.
  • Intracaudal - Administration within the cauda equina.
  • Perineural - Administration surrounding a nerve or nerves.
  • Labeler Name: [5]
    Labeler Code:
    0409
    FDA Application Number: [6]
    ANDA071168
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-18-2005
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 0409-9045?

    The NDC code 0409-9045 is assigned by the FDA to the product Bupivacaine Hydrochloride And Epinephrine which is a human prescription drug product labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via epidural; intracaudal; perineural form. The product is distributed in 2 packages with assigned NDC codes 0409-9045-01 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (0409-9045-11), 0409-9045-17 25 vial, single-dose in 1 tray / 30 ml in 1 vial, single-dose (0409-9045-16). 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 Bupivacaine Hydrochloride And Epinephrine?

    Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (See WARNINGS).Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients.Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block) (See WARNINGS).The routes of administration and indicated Bupivacaine Hydrochloride concentrations are:•local infiltration 0.25%•peripheral nerve block 0.25% and 0.5%•retrobulbar block 0.75%•sympathetic block 0.25%•lumbar epidural0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)•caudal0.25% and 0.5%•epidural test dose0.5% with epinephrine 1:200,000•dental blocks0.5% with epinephrine 1:200,000(See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride.

    What are Bupivacaine 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.
    • BUPIVACAINE HYDROCHLORIDE 5 mg/mL - A widely used local anesthetic agent.
    • 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 Bupivacaine Hydrochloride And Epinephrine UNII Codes?

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

    Which are Bupivacaine Hydrochloride And Epinephrine Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Bupivacaine 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".