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  5. NDC Package Code: 81052-138-10 Cytalux

NDC Package 81052-138-10 Cytalux

Pafolacianine Injection Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Product Code:
81052-138
Proprietary Name:
Cytalux
Non-Proprietary Name:
Pafolacianine Injection
Substance Name:
Pafolacianine Sodium
Usage Information:
CYTALUX™ is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
11-Digit NDC Billing Format:
81052013810
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
On Target Laboratories, Inc.
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PAFOLACIANINE SODIUM 3.2 mg/1.6mL
    • Pharmacologic Class(es):
  • Fluorescence Contrast Activity - [MoA] (Mechanism of Action)
  • Optical Imaging Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA214907
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-29-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 81052-138-10?

    The NDC Packaged Code 81052-138-10 is assigned to a package of 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1.6 ml in 1 vial, single-dose of Cytalux, a human prescription drug labeled by On Target Laboratories, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 81052-138 included in the NDC Directory?

    Yes, Cytalux with product code 81052-138 is active and included in the NDC Directory. The product was first marketed by On Target Laboratories, Inc. on November 29, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 81052-138-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 81052-138-10?

    The 11-digit format is 81052013810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-281052-138-105-4-281052-0138-10