Cerianna Injection
NDC Package 72874-001-01

11-digit billing NDC: 72874000101
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cerianna (fluoroestradiol f 18) injection is cERIANNA is indicated for use with positron emission tomography (PET imaging) for characterization of estrogen receptor (ER) status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer.Limitations of UseTissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology.  CERIANNA is not useful for imaigng other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). This formulation utilizes a injection delivery system. Marketed by Ge Healthcare Inc., this product is identified by NDC 72874-001 and is authorized under FDA application NDA212155.

Identification & Billing

NDC Package Code
72874-001-01
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
72874-001
11-Digit Billing Format
72874000101

Clinical Specifications

Proprietary Name
Cerianna
Non-Proprietary Name
Fluoroestradiol F 18
Substance Name
Fluoroestradiol 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)
FLUOROESTRADIOL F-18 100 mCi/mL
Pharmacologic Class
Usage Information
CERIANNA is indicated for use with positron emission tomography (PET imaging) for characterization of estrogen receptor (ER) status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer.Limitations of UseTissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology.  CERIANNA is not useful for imaigng other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR)

Regulatory & Marketing

Labeler Name
Ge Healthcare Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212155
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-20-2020
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 72874-001-01 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Cerianna, a human prescription drug labeled by Ge Healthcare Inc.. This injection is formulated for intravenous use and contains fluoroestradiol 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 Ge Healthcare Inc. on May 20, 2020. The current certification is valid through December 31, 2027.

How is this Ge Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72874000101. 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)
72874-001-01
11-Digit CMS (5-4-2)
72874-0001-01

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