Proleukin
NDC Package 65483-116-07

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Proleukin is aldesleukin is used to treat kidney or skin cancer. Marketed by Prometheus Laboratories Inc., this product is identified by NDC 65483-116 and is authorized under FDA application BLA103293.

Identification & Billing

NDC Package Code
65483-116-07
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code
65483-116
11-Digit Billing Format
65483011607
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Proleukin
Dosage Form
-
Usage Information
Aldesleukin is used to treat kidney or skin cancer. This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

Regulatory & Marketing

Labeler Name
Prometheus Laboratories Inc.
FDA Application #
BLA103293
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-05-1992
Listing Expiration
12-31-2020
Exclude Flag
I
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 65483-116-07 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Proleukin, labeled by Prometheus Laboratories Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Prometheus Laboratories Inc. on May 05, 1992. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

Aldesleukin is used to treat kidney or skin cancer. This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

How is this Prometheus Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65483011607. 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)
65483-116-07
11-Digit CMS (5-4-2)
65483-0116-07

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