NDC 69263-820 Pro-c-dure 5 Kit

Kenalog Kit Intra-articular; Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69263-820
Proprietary Name:
Pro-c-dure 5 Kit
Non-Proprietary Name: [1]
Kenalog
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]
  • Intra-articular - Administration within a joint.
  • Intramuscular - Administration within a muscle.
  • Labeler Name: [5]
    Oaklock, Llc
    Labeler Code:
    69263
    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]
    10-04-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 69263-820-01

    Package Description: 1 KIT in 1 CARTON * 1 VIAL in 1 CARTON (70121-1049-2) / 1 mL in 1 VIAL

    Product Details

    What is NDC 69263-820?

    The NDC code 69263-820 is assigned by the FDA to the product Pro-c-dure 5 Kit which is a human prescription drug product labeled by Oaklock, Llc. The generic name of Pro-c-dure 5 Kit is kenalog. The product's dosage form is kit and is administered via intra-articular; intramuscular form. The product is distributed in a single package with assigned NDC code 69263-820-01 1 kit in 1 carton * 1 vial in 1 carton (70121-1049-2) / 1 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 Pro-c-dure 5 Kit?

    Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

    Which are Pro-c-dure 5 Kit UNII Codes?

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

    • TRIAMCINOLONE ACETONIDE (UNII: F446C597KA)
    • TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (Active Moiety)

    Which are Pro-c-dure 5 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 Pro-c-dure 5 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:

    * 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.

    [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".