Trastuzumab Deruxtecan Injection, Powder, Lyophilized, For Solution
NDC Package 83703-580-01

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 Deruxtecan injection is a drug for further processing. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Bamboo Us Bidco Lcc, this product is identified by NDC 83703-580.

Identification & Billing

NDC Package Code
83703-580-01
Package Description
273 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
83703-580
11-Digit Billing Format
83703058001

Clinical Specifications

Proprietary Name
Trastuzumab Deruxtecan
Non-Proprietary Name
Trastuzumab Deruxtecan
Substance Name
Trastuzumab Deruxtecan
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 DERUXTECAN 100 mg/5mL

Regulatory & Marketing

Labeler Name
Bamboo Us Bidco Lcc
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
05-22-2019
Listing Expiration
12-31-2026
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 83703-580-01 identifies a specific commercial package of 273 vial, single-dose in 1 box / 5 ml in 1 vial, single-dose of Trastuzumab Deruxtecan (UNFINISHED drug), drug for further processing labeled by Bamboo Us Bidco Lcc. This injection, powder, lyophilized, for solution is formulated for use and contains trastuzumab deruxtecan 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 Bamboo Us Bidco Lcc on May 22, 2019. The current certification is valid through December 31, 2026.

How is this Bamboo Us Bidco Lcc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83703058001. 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)
83703-580-01
11-Digit CMS (5-4-2)
83703-0580-01

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