Fludeoxyglucose F 18 Injection
NDC Package 73410-003-01

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, USP is indicated for positron emission tomography (PET) imaging in the following settings:. This formulation utilizes a injection delivery system. Marketed by Sofie Co. Dba Sofie, this product is identified by NDC 73410-003 and is authorized under FDA application ANDA204463.

Identification & Billing

NDC Package Code
73410-003-01
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
73410-003
11-Digit Billing Format
73410000301

Clinical Specifications

Proprietary Name
Fludeoxyglucose F 18
Non-Proprietary Name
Fludeoxyglucose F 18
Substance Name
Fludeoxyglucose F-18
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)
FLUDEOXYGLUCOSE F-18 20 mCi/mL
Pharmacologic Class
Usage Information
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:

Regulatory & Marketing

Labeler Name
Sofie Co. Dba Sofie
Product Type
Human Prescription Drug
FDA Application #
ANDA204463
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-06-2019
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 73410-003-01 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of Fludeoxyglucose F 18, a human prescription drug labeled by Sofie Co. Dba Sofie. This injection 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 Sofie Co. Dba Sofie on November 06, 2019. The current certification is valid through December 31, 2026.

How is this Sofie Co. Dba Sofie product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73410000301. 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)
73410-003-01
11-Digit CMS (5-4-2)
73410-0003-01

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