Ambelvist Injection
NDC Package 50419-331-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ambelvist (gadoquatrane) injection is aMBELVIST is indicated in adult and pediatric patients, including term neonates, 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). This formulation utilizes a injection delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-331 and is authorized under FDA application NDA219627.

Identification & Billing

NDC Package Code
50419-331-11
Package Description
5 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (50419-331-01)
Product Code
50419-331
11-Digit Billing Format
50419033111

Clinical Specifications

Proprietary Name
Ambelvist
Non-Proprietary Name
Gadoquatrane
Substance Name
Gadoquatrane
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.
Active Ingredient(s)
GADOQUATRANE 257.9 mg/mL
Usage Information
AMBELVIST is indicated in adult and pediatric patients, including term neonates, 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)

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219627
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-12-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50419-331-11 identifies a specific commercial package of 5 syringe in 1 carton / 10 ml in 1 syringe (50419-331-01) of Ambelvist, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This injection is formulated for intravenous use and contains gadoquatrane 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 June 12, 2026. 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: 50419033111. 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)
50419-331-11
11-Digit CMS (5-4-2)
50419-0331-11

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