Ruby-fill Injection, Solution
NDC Package 65174-021-10

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

Package Information

Ruby-fill (rubidium rb 82) injection is rUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. This formulation utilizes a injection, solution delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 65174-021 and is authorized under FDA application NDA202153.

Identification & Billing

NDC Package Code
65174-021-10
Package Description
1 INJECTION, SOLUTION in 1 CONTAINER
Product Code
65174-021
11-Digit Billing Format
65174002110
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Ruby-fill
Non-Proprietary Name
Rubidium Rb 82
Substance Name
Rubidium Chloride Rb-82
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
RUBIDIUM CHLORIDE RB-82 100 mCi/1
Pharmacologic Class
Usage Information
RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
NDA202153
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-30-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65174-021-10 identifies a specific commercial package of 1 injection, solution in 1 container of Ruby-fill, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intravenous use and contains rubidium chloride rb-82 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 Jubilant Draximage Inc., Dba Jubilant Radiopharma on September 30, 2016. The current certification is valid through December 31, 2026.

How is this Jubilant Draximage Inc., Dba Jubilant Radiopharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65174002110. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
65174-021-10
11-Digit CMS (5-4-2)
65174-0021-10

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