Clariscan Injection, Solution
NDC Package 0407-2943-06

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

Clariscan (gadoterate meglumine) injection is clariscan 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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. This formulation utilizes a injection, solution delivery system. Marketed by Ge Healthcare, this product is identified by NDC 0407-2943 and is authorized under FDA application ANDA210016.

Identification & Billing

NDC Package Code
0407-2943-06
Package Description
10 VIAL, GLASS in 1 BOX / 5 mL in 1 VIAL, GLASS
Product Code
0407-2943
11-Digit Billing Format
00407294306
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Clariscan
Non-Proprietary Name
Gadoterate Meglumine
Substance Name
Gadoterate Meglumine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Clariscan 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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Additional pediatric use information is approved for Guerbet, LLC's Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC's marketing exclusivity, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Ge Healthcare
Product Type
Human Prescription Drug
FDA Application #
ANDA210016
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2019
Listing Expiration
12-31-2027
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 (0407-2943). Click a package code to view its specific billing and regulatory data.

0407-2943-01
10 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS
0407-2943-02
10 VIAL, GLASS in 1 BOX / 15 mL in 1 VIAL, GLASS
0407-2943-05
10 VIAL, GLASS in 1 BOX / 20 mL in 1 VIAL, GLASS
0407-2943-12
10 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC
0407-2943-17
10 SYRINGE, PLASTIC in 1 BOX / 15 mL in 1 SYRINGE, PLASTIC
0407-2943-22
10 SYRINGE, PLASTIC in 1 BOX / 20 mL in 1 SYRINGE, PLASTIC
0407-2943-70
10 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, 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 0407-2943-06 identifies a specific commercial package of 10 vial, glass in 1 box / 5 ml in 1 vial, glass of Clariscan, a human prescription drug labeled by Ge Healthcare. This injection, solution 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 Ge Healthcare on November 01, 2019. The current certification is valid through December 31, 2027.

How is this Ge Healthcare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00407294306. 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 (4-4-2)
0407-2943-06
11-Digit CMS (5-4-2)
00407-2943-06

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