Gadoterate Meglumine Injection
NDC Package 65219-080-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Gadoterate Meglumine injection is  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. This formulation utilizes a injection delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-080 and is authorized under FDA application ANDA215304.

Identification & Billing

NDC Package Code
65219-080-05
Package Description
10 CARTON in 1 BOX / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL
Product Code
65219-080
11-Digit Billing Format
65219008005
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Gadoterate Meglumine
Non-Proprietary Name
Gadoterate Meglumine
Substance Name
Gadoterate Meglumine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GADOTERATE MEGLUMINE 376.9 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215304
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-20-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65219-080-05 identifies a specific commercial package of 10 carton in 1 box / 1 vial in 1 carton (65219-080-01) / 5 ml in 1 vial of Gadoterate Meglumine, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection is formulated for intravenous use and contains gadoterate meglumine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on June 20, 2022. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219008005. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65219-080-05
11-Digit CMS (5-4-2)
65219-0080-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.