Beizray Injection, Solution
NDC Package 83513-009-01

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

Package Information

Beizray (docetaxel) injection is a medication used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). This formulation utilizes a injection, solution delivery system. Marketed by Zhuhai Beihai Biotech Co., Ltd., this product is identified by NDC 83513-009 and is authorized under FDA application NDA218711.

Identification & Billing

NDC Package Code
83513-009-01
Package Description
4 mL in 1 VIAL, GLASS
Product Code
83513-009
11-Digit Billing Format
83513000901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Beizray
Non-Proprietary Name
Docetaxel
Substance Name
Docetaxel Anhydrous
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOCETAXEL ANHYDROUS 20 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

Regulatory & Marketing

Labeler Name
Zhuhai Beihai Biotech Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA218711
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-23-2024
Listing Expiration
12-31-2026
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 83513-009-01 identifies a specific commercial package of 4 ml in 1 vial, glass of Beizray, a human prescription drug labeled by Zhuhai Beihai Biotech Co., Ltd.. This injection, solution is formulated for intravenous use and contains docetaxel anhydrous 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 Zhuhai Beihai Biotech Co., Ltd. on October 23, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

How is this Zhuhai Beihai Biotech Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83513000901. 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)
83513-009-01
11-Digit CMS (5-4-2)
83513-0009-01

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