Gadobutrol Injection
NDC Package 42337-005-02

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

Package Information

Gadobutrol injection 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 Viwit Pharmaceutical Co., Ltd., this product is identified by NDC 42337-005 and is authorized under FDA application ANDA219287.

Identification & Billing

NDC Package Code
42337-005-02
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (42337-005-01)
Product Code
42337-005
11-Digit Billing Format
42337000502

Clinical Specifications

Proprietary Name
Gadobutrol
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.
Active Ingredient(s)
GADOBUTROL 604.72 mg/mL
Pharmacologic Class
Usage Information
Gadobutrol Injection 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
Viwit Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA219287
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-11-2026
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 42337-005-02 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 7.5 ml in 1 vial, single-dose (42337-005-01) of Gadobutrol, a human prescription drug labeled by Viwit Pharmaceutical Co., Ltd.. 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 Viwit Pharmaceutical Co., Ltd. on June 11, 2026. The current certification is valid through December 31, 2027.

How is this Viwit Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42337000502. 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)
42337-005-02
11-Digit CMS (5-4-2)
42337-0005-02

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