NDC 0407-2943-01 Clariscan

Gadoterate Meglumine Injection, Solution Intravenous

NDC Package Code 0407-2943-01

The NDC Code 0407-2943-01 is assigned to a package of 10 vial, glass in 1 box > 10 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.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

Field Name Field Value
NDC Code 0407-2943-01
Package Description 10 VIAL, GLASS in 1 BOX > 10 mL in 1 VIAL, GLASS
Product Code 0407-2943
Proprietary Name Clariscan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Gadoterate Meglumine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses 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 00407294301 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 100 ML
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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.
Active Ingredient(s)
Pharmacologic Class(es)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANDA210016 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC 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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0407-2943-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00407294301A9575Inj gadoterate meglumi 0.1ml0.1 ML10101001000

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Other Product Packages

The following packages are also available for Clariscan with product NDC 0407-2943.

NDC Package CodePackage Description
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
0407-2943-0610 VIAL, GLASS in 1 BOX > 5 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.