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  4. NDC Product Code: 66658-234 Kineret

NDC 66658-234 Kineret

Anakinra Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 66658-234?
  4. Kineret Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
66658-234
Proprietary Name:
Kineret
Non-Proprietary Name: [1]
Anakinra
Substance Name: [2]
Anakinra
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]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Swedish Orphan Biovitrum Ab (publ)
    Labeler Code:
    66658
    Product Label ID:
    d9d74915-6606-4570-9c52-c4001d3177de
    FDA Application Number: [6]
    BLA103950
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    12-15-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 66658-234?

    The NDC code 66658-234 is assigned by the FDA to the product Kineret which is a human prescription drug product labeled by Swedish Orphan Biovitrum Ab (publ). The generic name of Kineret is anakinra. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 66658-234-07 7 syringe, glass in 1 carton / .67 ml in 1 syringe, glass, 66658-234-28 4 carton in 1 case / 7 syringe, glass in 1 carton (66658-234-07) / .67 ml in 1 syringe, glass. 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 Kineret?

    This medication is used alone or with other medications to treat rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling caused by rheumatoid arthritis so that you can move better. Anakinra is a man-made form of a natural protein (interleukin-1 receptor antagonist) made by the body. It helps to block the effects of another protein (interleukin-1) which can cause joint pain/swelling/stiffness. Anakinra is also used to treat a certain condition called Neonatal-Onset Multisystem Inflammatory Disease (NOMID). It helps to improve symptoms of the disease such as fever, rash, joint pain, vomiting, and headache.

    What are Kineret 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.
    • ANAKINRA 100 mg/.67mL - A ligand that binds to but fails to activate the INTERLEUKIN 1 RECEPTOR. It plays an inhibitory role in the regulation of INFLAMMATION and FEVER. Several isoforms of the protein exist due to multiple ALTERNATIVE SPLICING of its mRNA.

    Which are Kineret UNII Codes?

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

    Which are Kineret 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 Kineret?

    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:

    Which are the Pharmacologic Classes for Kineret?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Anakinra


    Anakinra is used alone or in combination with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who were not helped by other disease-modifying antirheumatic drugs (DMARDs). Anakinra is also used to treat neonatal-onset multisystem inflammatory disease (NOMID; a disorder that causes inflammation and damages the nervous system, skin, and joints) in adults and children. Anakinra is also used to treat deficiency of interleukin-1 receptor antagonist (DIRA; a disorder in which the body attacks its own tissues causing inflammation and damages bones, nervous system, skin, lungs, liver, and joints) in adults and children. Anakinra is authorized for the treatment of coronavirus disease 2019 (COVID-19 infection) in hospitalized adults who require supplemental oxygen, a ventilator, or who need extracorporeal membrane oxygenation (ECMO; a device that adds oxygen to the blood). Anakinra is in a class of medications called interleukin antagonists. It works by blocking the activity of interleukin, a substance in the body that causes inflammation.
    [Learn More]


    * 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.

    [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".