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  5. NDC Package Code: 65219-590-04 Tyenne

NDC Package 65219-590-04 Tyenne

Tocilizumab-aazg Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65219-590-04
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code:
65219-590
Proprietary Name:
Tyenne
Non-Proprietary Name:
Tocilizumab-aazg
Substance Name:
Tocilizumab
Usage Information:
This medication is used alone or with other medications to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat rheumatoid arthritis in children (such as systemic juvenile idiopathic arthritis-SJIA, polyarticular juvenile idiopathic arthritis-PJIA). It helps to reduce pain and swelling due to rheumatoid arthritis. Tocilizumab may also be used to treat a reaction (Cytokine Release Syndrome-CRS) caused by certain cancer treatments. Tocilizumab belongs to a class of drugs known as Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a substance made by the body that causes swelling (inflammation).
11-Digit NDC Billing Format:
65219059004
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2679431 - tocilizumab-aazg 80 MG in 4 ML Injection
  • RxCUI: 2679431 - 4 ML tocilizumab-aazg 20 MG/ML Injection
  • RxCUI: 2679431 - tocilizumab-aazg 80 MG per 4 ML Injection
  • RxCUI: 2679438 - Tyenne 80 MG in 4 ML Injection
  • RxCUI: 2679438 - 4 ML tocilizumab-aazg 20 MG/ML Injection [Tyenne]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TOCILIZUMAB 80 mg/4mL
    • Pharmacologic Class(es):
  • Interleukin 6 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Interleukin-6 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761275
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-15-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65219-590-04?

    The NDC Packaged Code 65219-590-04 is assigned to a package of 1 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Tyenne, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 65219-590 included in the NDC Directory?

    Yes, Tyenne with product code 65219-590 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on April 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65219-590-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 65219-590-04?

    The 11-digit format is 65219059004. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265219-590-045-4-265219-0590-04