Fludeoxyglucose F 18 Injection, Solution
NDC Package 60055-334-30

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

Package Information

Fludeoxyglucose F 18 injection is fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:. This formulation utilizes a injection, solution delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 60055-334 and is authorized under FDA application ANDA203920.

Identification & Billing

NDC Package Code
60055-334-30
Package Description
30 mL in 1 VIAL
Product Code
60055-334
11-Digit Billing Format
60055033430

Clinical Specifications

Proprietary Name
Fludeoxyglucose F 18
Non-Proprietary Name
Fludeoxyglucose F-18
Substance Name
Fludeoxyglucose F-18
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)
FLUDEOXYGLUCOSE F-18 300 mCi/mL
Pharmacologic Class
Usage Information
Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
ANDA203920
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2010
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 60055-334-30 identifies a specific commercial package of 30 ml in 1 vial of Fludeoxyglucose F 18, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. This injection, solution is formulated for intravenous use and contains fludeoxyglucose f-18 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 November 20, 2010. The current certification is valid through December 31, 2027.

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: 60055033430. 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)
60055-334-30
11-Digit CMS (5-4-2)
60055-0334-30

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