Gadobutrol Injection
NDC Package 70436-217-80

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

Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection. This formulation utilizes a injection delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-217 and is authorized under FDA application ANDA217480.

Identification & Billing

NDC Package Code
70436-217-80
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-38)
Product Code
70436-217
11-Digit Billing Format
70436021780

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.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217480
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-16-2025
Listing Expiration
12-31-2026
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 (70436-217). Click a package code to view its specific billing and regulatory data.

70436-217-50
1 VIAL, MULTI-DOSE in 1 CARTON / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-78)

* 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 70436-217-80 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 65 ml in 1 vial, multi-dose (70436-217-38) of Gadobutrol, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. 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 Slate Run Pharmaceuticals, Llc on April 16, 2025. The current certification is valid through December 31, 2026.

How is this Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436021780. 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)
70436-217-80
11-Digit CMS (5-4-2)
70436-0217-80

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