Indium In 111 Oxyquinoline Liquid
NDC Package 72536-0920-1

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

Package Information

Indium In 111 Oxyquinoline liquids is indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes.Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. This formulation utilizes a liquid delivery system. Marketed by Bwxt Medical Ltd., this product is identified by NDC 72536-0920 and is authorized under FDA application ANDA202586.

Identification & Billing

NDC Package Code
72536-0920-1
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
72536-0920
11-Digit Billing Format
72536092001

Clinical Specifications

Proprietary Name
Indium In 111 Oxyquinoline
Non-Proprietary Name
Indium In-111 Oxyquinoline
Substance Name
Indium In-111 Oxyquinoline
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
INDIUM IN-111 OXYQUINOLINE 1 mCi/mL
Usage Information
Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes.Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation of patients with a high clinical probability of an abscess in a known location. Ultrasound or computed tomography may provide a better anatomical delineation of the infectious process and information may be obtained more quickly than with labeled leukocytes. If localization by these techniques is successful, labeled leukocytes should not be used as a confirmatory procedure. If localization or diagnosis by these methods fails or is ambiguous, indium In 111 oxyquinoline labeled leukocyte imaging may be appropriate.

Regulatory & Marketing

Labeler Name
Bwxt Medical Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA202586
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-27-2019
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 72536-0920-1 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Indium In 111 Oxyquinoline, a human prescription drug labeled by Bwxt Medical Ltd.. This liquid is formulated for intravenous use and contains indium in-111 oxyquinoline 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 Bwxt Medical Ltd. on September 27, 2019. The current certification is valid through December 31, 2026.

How is this Bwxt Medical Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72536092001. 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 (5-4-1)
72536-0920-1
11-Digit CMS (5-4-2)
72536-0920-01

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