Gadavist Injection
NDC Package 50419-325-28

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

Gadavist (gadobutrol) injection is gADAVIST is indicated for:Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonatesMRI of the breast to assess the presence and extent of malignant breast disease in adult patientsMagnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonatesCardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). This formulation utilizes a injection delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-325 and is authorized under FDA application NDA201277.

Identification & Billing

NDC Package Code
50419-325-28
Package Description
5 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS
Product Code
50419-325
11-Digit Billing Format
50419032528
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Gadavist
Non-Proprietary Name
Gadobutrol
Substance Name
Gadobutrol
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • 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
GADAVIST is indicated for:Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonatesMRI of the breast to assess the presence and extent of malignant breast disease in adult patientsMagnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonatesCardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD)

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA201277
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-2011
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 (50419-325). Click a package code to view its specific billing and regulatory data.

50419-325-11
2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE
50419-325-12
2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
50419-325-13
2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
50419-325-14
2 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
50419-325-15
10 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS
50419-325-18
2 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
50419-325-19
10 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS
50419-325-27
5 SYRINGE, GLASS in 1 BOX / 7.5 mL in 1 SYRINGE, GLASS
50419-325-29
5 SYRINGE, GLASS in 1 BOX / 15 mL in 1 SYRINGE, GLASS
50419-325-37
15 CARTON in 1 BOX / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
50419-325-72
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
50419-325-73
30 mL in 1 BOTTLE, GLASS
50419-325-74
65 mL in 1 BOTTLE, GLASS
50419-325-75
5 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS

* 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 50419-325-28 identifies a specific commercial package of 5 syringe, glass in 1 box / 10 ml in 1 syringe, glass of Gadavist, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This injection is formulated for intravenous use and contains gadobutrol 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 Bayer Healthcare Pharmaceuticals Inc. on March 14, 2011. The current certification is valid through December 31, 2027.

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419032528. 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 (5-3-2)
50419-325-28
11-Digit CMS (5-4-2)
50419-0325-28

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