Fludeoxyglucose F-18 Injection
NDC Package 65857-150-30

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 indicated for positron emission tomography (PET) imaging in the following settings:. This formulation utilizes a injection delivery system. Marketed by Cardinal Health 414, Llc, this product is identified by NDC 65857-150 and is authorized under FDA application ANDA203603.

Identification & Billing

NDC Package Code
65857-150-30
Package Description
30 mL in 1 VIAL, GLASS
Product Code
65857-150
11-Digit Billing Format
65857015030
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
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-18 500 mCi/mL
Pharmacologic Class
Usage Information
Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Regulatory & Marketing

Labeler Name
Cardinal Health 414, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203603
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2019
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 65857-150-30 identifies a specific commercial package of 30 ml in 1 vial, glass of Fludeoxyglucose F-18, a human prescription drug labeled by Cardinal Health 414, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Cardinal Health 414, Llc on January 02, 2019. The current certification is valid through December 31, 2026.

How is this Cardinal Health 414, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65857015030. 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)
65857-150-30
11-Digit CMS (5-4-2)
65857-0150-30

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