Bortezomib Injection, Powder, Lyophilized, For Solution
NDC Package 83090-008-01

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

Package Information

Bortezomib injection is a medication used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Sintetica Us Llc, this product is identified by NDC 83090-008 and is authorized under FDA application ANDA209622.

Identification & Billing

NDC Package Code
83090-008-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 3.5 mL in 1 VIAL, SINGLE-DOSE
Product Code
83090-008
11-Digit Billing Format
83090000801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
RxCUI: 402243 - bortezomib 3.5 MG Injection

Clinical Specifications

Proprietary Name
Bortezomib
Non-Proprietary Name
Bortezomib
Substance Name
Bortezomib
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.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BORTEZOMIB 3.5 mg/3.5mL
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Sintetica Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209622
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2023
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 83090-008-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 3.5 ml in 1 vial, single-dose of Bortezomib, a human prescription drug labeled by Sintetica Us Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous; subcutaneous use and contains bortezomib 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 Sintetica Us Llc on July 15, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma). It works by slowing or stopping the growth of cancer cells.

How is this Sintetica Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83090000801. 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)
83090-008-01
11-Digit CMS (5-4-2)
83090-0008-01

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