NDC Package 65219-082-10 Gadoterate Meglumine

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

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:
65219-082-10
Package Description:
10 CARTON in 1 BOX / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL
Product Code:
Proprietary Name:
Gadoterate Meglumine
Non-Proprietary Name:
Gadoterate Meglumine
Substance Name:
Gadoterate Meglumine
Usage Information:
Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
11-Digit NDC Billing Format:
65219008210
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):
    Sample Package:
    No
    FDA Application Number:
    ANDA215304
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-20-2022
    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.

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    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 65219-082-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    65219008210A9575Inj gadoterate meglumi 0.1ml0.1 ML10101001000

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    Frequently Asked Questions

    What is NDC 65219-082-10?

    The NDC Packaged Code 65219-082-10 is assigned to a package of 10 carton in 1 box / 1 vial in 1 carton (65219-082-01) / 10 ml in 1 vial of Gadoterate Meglumine, 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 65219-082 included in the NDC Directory?

    Yes, Gadoterate Meglumine with product code 65219-082 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on June 20, 2022 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 65219-082-10?

    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 65219-082-10?

    The 11-digit format is 65219008210. 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
    5-3-265219-082-105-4-265219-0082-10