Dotarem Injection
NDC Package 67684-3001-2

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

Package Information

Dotarem (gadoterate meglumine) injection is dOTAREM 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 Guerbet Llc, this product is identified by NDC 67684-3001 and is authorized under FDA application NDA204781.

Identification & Billing

NDC Package Code
67684-3001-2
Package Description
10 SYRINGE, PLASTIC in 1 PACKAGE / 15 mL in 1 SYRINGE, PLASTIC
Product Code
67684-3001
11-Digit Billing Format
67684300102

Clinical Specifications

Proprietary Name
Dotarem
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
DOTAREM 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
Guerbet Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204781
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-18-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67684-3001). Click a package code to view its specific billing and regulatory data.

67684-3001-1
10 SYRINGE, PLASTIC in 1 PACKAGE / 10 mL in 1 SYRINGE, PLASTIC
67684-3001-3
10 SYRINGE, PLASTIC in 1 PACKAGE / 20 mL in 1 SYRINGE, PLASTIC

* 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 67684-3001-2 identifies a specific commercial package of 10 syringe, plastic in 1 package / 15 ml in 1 syringe, plastic of Dotarem, a human prescription drug labeled by Guerbet 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 Guerbet Llc on September 18, 2019. The current certification is valid through December 31, 2026.

How is this Guerbet Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67684300102. 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 (5-4-1)
67684-3001-2
11-Digit CMS (5-4-2)
67684-3001-02

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