Trastuzumab Emtansine Drug Product 100 Mg Injection, Powder, Lyophilized, For Solution
NDC Package 43624-040-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Trastuzumab Emtansine Drug Product 100 Mg injection is a drug for further processing. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Bsp Pharmaceuticals S.p.a., this product is identified by NDC 43624-040.

Identification & Billing

NDC Package Code
43624-040-01
Package Description
3 TRAY in 1 BOX / 143 VIAL in 1 TRAY / 5 mL in 1 VIAL
Product Code
43624-040
11-Digit Billing Format
43624004001

Clinical Specifications

Proprietary Name
Trastuzumab Emtansine Drug Product 100 Mg
Non-Proprietary Name
Trastuzumab Emtansine Drug Product 100 Mg
Substance Name
Trastuzumab Emtansine
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
TRASTUZUMAB EMTANSINE 20 mg/mL

Regulatory & Marketing

Labeler Name
Bsp Pharmaceuticals S.p.a.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-22-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 43624-040-01 identifies a specific commercial package of 3 tray in 1 box / 143 vial in 1 tray / 5 ml in 1 vial of Trastuzumab Emtansine Drug Product 100 Mg (UNFINISHED drug), drug for further processing labeled by Bsp Pharmaceuticals S.p.a.. This injection, powder, lyophilized, for solution is formulated for use and contains trastuzumab emtansine 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 S.p.a. on February 22, 2013. The current certification is valid through December 31, 2027.

How is this Bsp Pharmaceuticals S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43624004001. 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)
43624-040-01
11-Digit CMS (5-4-2)
43624-0040-01

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