NDC 76420-750 Dyural 40 Kit

Methylprednisolone Acetate,Lidocaine Hydrochloride,Bupivacaine Hydrochloride,Povidine - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
76420-750
Proprietary Name:
Dyural 40 Kit
Non-Proprietary Name: [1]
Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
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.
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Soft Tissue - Administration into any soft tissue.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Asclemed Usa, Inc.
    Labeler Code:
    76420
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    07-25-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 76420-750-01

    Package Description: 1 KIT in 1 CARTON * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * 5 mL in 1 POUCH * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 76420-750?

    The NDC code 76420-750 is assigned by the FDA to the product Dyural 40 Kit which is a human prescription drug product labeled by Asclemed Usa, Inc.. The generic name of Dyural 40 Kit is methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, isopropyl alcohol. The product's dosage form is kit and is administered via epidural; infiltration; intra-articular; intralesional; intramuscular; intravenous; soft tissue; subcutaneous; topical form. The product is distributed in a single package with assigned NDC code 76420-750-01 1 kit in 1 carton * .9 ml in 1 packet (67777-419-02) * 10 ml in 1 vial, plastic (0409-4887-17) * 10 ml in 1 vial, single-dose (0409-4888-02) * 5 ml in 1 pouch * 10 ml in 1 vial, single-dose (0409-1159-18) * 10 vial, single-dose in 1 carton (55150-162-05) / 5 ml in 1 vial, single-dose * 25 vial, single-dose in 1 carton (70121-1573-5) / 1 ml in 1 vial, single-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 Dyural 40 Kit?

    DEPO-MEDROL is contraindicated in patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.DEPO-MEDROL is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route. DEPO-MEDROL is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections). Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Bupivacaine hydrochloride injection is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. Bupivacaine hydrochloride injection is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. Sterile Water for Injection, USP must be made approximately isotonic prior to use.

    Which are Dyural 40 Kit UNII Codes?

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

    Which are Dyural 40 Kit 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:

    What is the NDC to RxNorm Crosswalk for Dyural 40 Kit?

    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:

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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.

    [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.

    [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".