Cytalux Injection
NDC Package 81052-138-10

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

Package Information

Cytalux (pafolacianine injection) injection is cYTALUX™ is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. This formulation utilizes a injection delivery system. Marketed by On Target Laboratories, Inc., this product is identified by NDC 81052-138 and is authorized under FDA application NDA214907.

Identification & Billing

NDC Package Code
81052-138-10
Package Description
10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01)
Product Code
81052-138
11-Digit Billing Format
81052013810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cytalux
Non-Proprietary Name
Pafolacianine Injection
Substance Name
Pafolacianine Sodium
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)
PAFOLACIANINE SODIUM 3.2 mg/1.6mL
Pharmacologic Class
Usage Information
CYTALUX™ is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

Regulatory & Marketing

Labeler Name
On Target Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214907
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-29-2021
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 81052-138-10 identifies a specific commercial package of 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1.6 ml in 1 vial, single-dose (81052-138-01) of Cytalux, a human prescription drug labeled by On Target Laboratories, Inc.. This injection is formulated for intravenous use and contains pafolacianine sodium 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 On Target Laboratories, Inc. on November 29, 2021. The current certification is valid through December 31, 2027.

How is this On Target Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81052013810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
81052-138-10
11-Digit CMS (5-4-2)
81052-0138-10

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