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  5. NDC Package Code: 65219-281-02 Gadobutrol

NDC Package 65219-281-02 Gadobutrol

Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
65219-281-02
Package Description:
5 CARTON in 1 BOX / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)
Product Code:
65219-281
Proprietary Name:
Gadobutrol
Non-Proprietary Name:
Gadobutrol
Substance Name:
Gadobutrol
Usage Information:
Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection.
11-Digit NDC Billing Format:
65219028102
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Fresenius Kabi Usa, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GADOBUTROL 604.72 mg/mL
    • Pharmacologic Class(es):
  • Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA215061
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-14-2023
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 65219-281-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    65219028102A9585Gadobutrol injection0.1 ML21520300

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65219-281-072 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
    65219-281-102 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
    65219-281-152 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65219-281-02?

    The NDC Packaged Code 65219-281-02 is assigned to a package of 5 carton in 1 box / 3 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose (65219-281-00) of Gadobutrol, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 65219-281 included in the NDC Directory?

    Yes, Gadobutrol with product code 65219-281 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on April 14, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65219-281-02?

    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 65219-281-02?

    The 11-digit format is 65219028102. 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
    5-3-265219-281-025-4-265219-0281-02