Gadoquatrane Injection
NDC Package 12866-3230-2

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Gadoquatrane injection is a drug for further processing. This formulation utilizes a injection delivery system. Marketed by Bayer Ag, this product is identified by NDC 12866-3230.

Identification & Billing

NDC Package Code
12866-3230-2
Package Description
7.5 mL in 1 VIAL, SINGLE-DOSE
Product Code
12866-3230
11-Digit Billing Format
12866323002

Clinical Specifications

Proprietary Name
Gadoquatrane
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.
Active Ingredient(s)
GADOQUATRANE 257.9 mg/mL

Regulatory & Marketing

Labeler Name
Bayer Ag
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-12-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (12866-3230). Click a package code to view its specific billing and regulatory data.

12866-3230-1
2 mL in 1 VIAL, SINGLE-DOSE
12866-3230-3
10 mL in 1 VIAL, SINGLE-DOSE

* 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 12866-3230-2 identifies a specific commercial package of 7.5 ml in 1 vial, single-dose of Gadoquatrane (UNFINISHED drug), drug for further processing labeled by Bayer Ag. This injection is formulated for 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 Ag on June 12, 2026. The current certification is valid through December 31, 2027.

How is this Bayer Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12866323002. 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 (5-4-1)
12866-3230-2
11-Digit CMS (5-4-2)
12866-3230-02

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