NDC Package 0407-2943-06 Clariscan

Gadoterate Meglumine Injection, Solution 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:
0407-2943-06
Package Description:
10 VIAL, GLASS in 1 BOX / 5 mL in 1 VIAL, GLASS
Product Code:
Proprietary Name:
Clariscan
Non-Proprietary Name:
Gadoterate Meglumine
Substance Name:
Gadoterate Meglumine
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.
11-Digit NDC Billing Format:
00407294306
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:
Ge Healthcare
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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA210016
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2019
    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.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0407-2943-0110 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS
    0407-2943-0210 VIAL, GLASS in 1 BOX / 15 mL in 1 VIAL, GLASS
    0407-2943-0510 VIAL, GLASS in 1 BOX / 20 mL in 1 VIAL, GLASS
    0407-2943-1210 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC
    0407-2943-1710 SYRINGE, PLASTIC in 1 BOX / 15 mL in 1 SYRINGE, PLASTIC
    0407-2943-2210 SYRINGE, PLASTIC in 1 BOX / 20 mL in 1 SYRINGE, PLASTIC
    0407-2943-7010 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0407-2943-06?

    The NDC Packaged Code 0407-2943-06 is assigned to a package of 10 vial, glass in 1 box / 5 ml in 1 vial, glass of Clariscan, a human prescription drug labeled by Ge Healthcare. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0407-2943 included in the NDC Directory?

    Yes, Clariscan with product code 0407-2943 is active and included in the NDC Directory. The product was first marketed by Ge Healthcare on November 01, 2019 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 0407-2943-06?

    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 0407-2943-06?

    The 11-digit format is 00407294306. 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 4-4-2 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
    4-4-20407-2943-065-4-200407-2943-06