Fludeoxyglucose Injection
NDC Package 76326-001-20

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

Package Information

Fludeoxyglucose (fludeoxyglucose f18) injection is fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:. This formulation utilizes a injection delivery system. Marketed by The Regents Of The University Of Michigan, this product is identified by NDC 76326-001 and is authorized under FDA application ANDA204531.

Identification & Billing

NDC Package Code
76326-001-20
Package Description
19 mL in 1 VIAL, GLASS
Product Code
76326-001
11-Digit Billing Format
76326000120

Clinical Specifications

Proprietary Name
Fludeoxyglucose F18
Non-Proprietary Name
Fludeoxyglucose F18
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-18 300 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
The Regents Of The University Of Michigan
Product Type
Human Prescription Drug
FDA Application #
ANDA204531
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-17-2015
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 76326-001-20 identifies a specific commercial package of 19 ml in 1 vial, glass of Fludeoxyglucose F18, a human prescription drug labeled by The Regents Of The University Of Michigan. 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 The Regents Of The University Of Michigan on July 17, 2015. The current certification is valid through December 31, 2026.

How is this The Regents Of The University Of Michigan product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76326000120. 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)
76326-001-20
11-Digit CMS (5-4-2)
76326-0001-20

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