Halaven Injection
NDC Package 43624-002-01

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

Package Information

Halaven (eribulin mesylate) injection is eribulin is used to treat certain types of cancer (breast, liposarcoma). This formulation utilizes a injection delivery system. Marketed by Bsp Pharmaceuticals Spa, this product is identified by NDC 43624-002 and is authorized under FDA application NDA201532.

Identification & Billing

NDC Package Code
43624-002-01
Package Description
100 VIAL in 1 TRAY / 2 mL in 1 VIAL
Product Code
43624-002
11-Digit Billing Format
43624000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Halaven
Non-Proprietary Name
Eribulin Mesylate
Substance Name
Eribulin Mesylate
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)
ERIBULIN MESYLATE 1 mg/2mL
Pharmacologic Class
Usage Information
Eribulin is used to treat certain types of cancer (breast, liposarcoma). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Bsp Pharmaceuticals Spa
Product Type
Human Prescription Drug
FDA Application #
NDA201532
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-21-2017
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 43624-002-01 identifies a specific commercial package of 100 vial in 1 tray / 2 ml in 1 vial of Halaven, a human prescription drug labeled by Bsp Pharmaceuticals Spa. This injection is formulated for intravenous use and contains eribulin mesylate 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 Bsp Pharmaceuticals Spa on April 21, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Eribulin is used to treat certain types of cancer (breast, liposarcoma). It works by slowing or stopping the growth of cancer cells.

How is this Bsp Pharmaceuticals Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43624000201. 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)
43624-002-01
11-Digit CMS (5-4-2)
43624-0002-01

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