NDC Package 67684-4230-1 Elucirem

Gadopiclenol Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

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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:

67684-4230-1

Package Description:

1 VIAL in 1 CARTON / 3 mL in 1 VIAL

Product Code:

67684-4230

Proprietary Name:

Elucirem

Non-Proprietary Name:

Gadopiclenol

Substance Name:

Gadopiclenol

Usage Information:

ELUCIREMTM is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:the central nervous system (brain, spine, and associated tissues),the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

11-Digit NDC Billing Format:

67684423001

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.

Active Ingredient(s):

GADOPICLENOL 485.1 mg/mL

Sample Package:

FDA Application Number:

NDA216986

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

09-21-2022

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

67684 - Guerbet Llc
- 67684-4230 - Elucirem
  - 67684-4230-1 - 1 VIAL in 1 CARTON / 3 mL in 1 VIAL

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 Code	Package Description
67684-4230-2	10 VIAL in 1 CARTON / 3 mL in 1 VIAL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 67684-4230-1?

The NDC Packaged Code 67684-4230-1 is assigned to a package of 1 vial in 1 carton / 3 ml in 1 vial of Elucirem, a human prescription drug labeled by Guerbet Llc. The product's dosage form is injection and is administered via intravenous form.

Is NDC 67684-4230 included in the NDC Directory?

Yes, Elucirem with product code 67684-4230 is active and included in the NDC Directory. The product was first marketed by Guerbet Llc on September 21, 2022 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 67684-4230-1?

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 67684-4230-1?

The 11-digit format is 67684423001. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	67684-4230-1	5-4-2	67684-4230-01

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