Leukine
NDC Package 50419-002-33

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 discontinued by the firm.

Leukine is sargramostim is a man-made version of a certain natural substance made in your body. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-002 and is authorized under FDA application BLA103362.

Identification & Billing

NDC Package Code
50419-002-33
Package Description
5 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
50419-002
11-Digit Billing Format
50419000233
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Leukine
Dosage Form
-
Usage Information
Sargramostim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Sargramostim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant).

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
FDA Application #
BLA103362
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-05-1991
End Marketing Date
09-21-2012
Listing Expiration
09-21-2012
Exclude Flag
D
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 50419-002-33 identifies a specific commercial package of 5 vial in 1 carton / 1 ml in 1 vial of Leukine, labeled by Bayer Healthcare Pharmaceuticals 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 Bayer Healthcare Pharmaceuticals Inc. on September 05, 1991. The current certification is valid through September 21, 2012.

What are the primary indications for this medication?

Sargramostim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Sargramostim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419000233. 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)
50419-002-33
11-Digit CMS (5-4-2)
50419-0002-33

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