Elotuzumab Injection, Powder, Lyophilized, For Solution
NDC Package 83157-2291-9

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.

Elotuzumab injection is a medication used to treat a certain type of cancer (multiple myeloma). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Lotte Biologics Usa, Llc, this product is identified by NDC 83157-2291.

Identification & Billing

NDC Package Code
83157-2291-9
Package Description
6.3 kg in 1 BAG
Product Code
83157-2291
11-Digit Billing Format
83157229109

Clinical Specifications

Proprietary Name
Elotuzumab
Non-Proprietary Name
Elotuzumab
Substance Name
Elotuzumab
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)
ELOTUZUMAB 1 kg/kg
Usage Information
This medication is used to treat a certain type of cancer (multiple myeloma). Elotuzumab belongs to a class of dugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Lotte Biologics Usa, Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-30-2015
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 83157-2291-9 identifies a specific commercial package of 6.3 kg in 1 bag of Elotuzumab (UNFINISHED drug), a bulk ingredient labeled by Lotte Biologics Usa, Llc. This injection, powder, lyophilized, for solution is formulated for use and contains elotuzumab 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 Lotte Biologics Usa, Llc on November 30, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of cancer (multiple myeloma). Elotuzumab belongs to a class of dugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

How is this Lotte Biologics Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83157229109. 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 (5-4-1)
83157-2291-9
11-Digit CMS (5-4-2)
83157-2291-09

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