NDC Package 67684-2001-3 Dotarem

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:
67684-2001-3
Package Description:
10 VIAL in 1 PACKAGE / 20 mL in 1 VIAL
Product Code:
Proprietary Name:
Dotarem
Non-Proprietary Name:
Gadoterate Meglumine
Substance Name:
Gadoterate Meglumine
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.
11-Digit NDC Billing Format:
67684200103
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:
Guerbet 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.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    NDA204781
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-26-2013
    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
    67684-2001-010 VIAL in 1 PACKAGE / 5 mL in 1 VIAL
    67684-2001-110 VIAL in 1 PACKAGE / 10 mL in 1 VIAL
    67684-2001-210 VIAL in 1 PACKAGE / 15 mL in 1 VIAL
    67684-2001-46 VIAL in 1 PACKAGE / 100 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67684-2001-3?

    The NDC Packaged Code 67684-2001-3 is assigned to a package of 10 vial in 1 package / 20 ml in 1 vial of Dotarem, a human prescription drug labeled by Guerbet Llc. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 67684-2001 included in the NDC Directory?

    Yes, Dotarem with product code 67684-2001 is active and included in the NDC Directory. The product was first marketed by Guerbet Llc on April 26, 2013 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 67684-2001-3?

    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 67684-2001-3?

    The 11-digit format is 67684200103. 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 5-4-1 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
    5-4-167684-2001-35-4-267684-2001-03