Ipilimumab Injection
NDC Package 83157-2327-9

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.

Ipilimumab injection is ipilimumab is used to treat various cancers (such as skin, kidney, liver, lung, colorectal). This formulation utilizes a injection delivery system. Marketed by Lotte Biologics Usa, Llc, this product is identified by NDC 83157-2327.

Identification & Billing

NDC Package Code
83157-2327-9
Package Description
85 kg in 1 BAG
Product Code
83157-2327
11-Digit Billing Format
83157232709

Clinical Specifications

Proprietary Name
Ipilimumab
Non-Proprietary Name
Ipilimumab
Substance Name
Ipilimumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
IPILIMUMAB 1 kg/kg
Usage Information
Ipilimumab is used to treat various cancers (such as skin, kidney, liver, lung, colorectal). Ipilimumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. However, it can have serious side effects in other parts of your body (see also Side Effects section).

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
03-25-2011
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 83157-2327-9 identifies a specific commercial package of 85 kg in 1 bag of Ipilimumab (UNFINISHED drug), a bulk ingredient labeled by Lotte Biologics Usa, Llc. This injection is formulated for use and contains ipilimumab 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 March 25, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ipilimumab is used to treat various cancers (such as skin, kidney, liver, lung, colorectal). Ipilimumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. However, it can have serious side effects in other parts of your body (see also Side Effects section).

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: 83157232709. 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)
83157-2327-9
11-Digit CMS (5-4-2)
83157-2327-09

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