Durvalumab Liquid
NDC Package 71124-0030-0

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.

Durvalumab liquids is durvalumab is used to treat a certain type of bladder and urinary tract cancer. This formulation utilizes a liquid delivery system. Marketed by Samsung Biologics Co., Ltd., this product is identified by NDC 71124-0030.

Identification & Billing

NDC Package Code
71124-0030-0
Package Description
200 kg in 1 BAG
Product Code
71124-0030
11-Digit Billing Format
71124003000

Clinical Specifications

Proprietary Name
Durvalumab
Non-Proprietary Name
Durvalumab
Substance Name
Durvalumab
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
DURVALUMAB 200 kg/200kg
Usage Information
Durvalumab is used to treat a certain type of bladder and urinary tract cancer. It is also used to treat lung cancer. It works by helping your immune system fight the cancer. This medication belongs to a class of drugs known as monoclonal antibodies.

Regulatory & Marketing

Labeler Name
Samsung Biologics Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-05-2017
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 71124-0030-0 identifies a specific commercial package of 200 kg in 1 bag of Durvalumab (UNFINISHED drug), a bulk ingredient labeled by Samsung Biologics Co., Ltd.. This liquid is formulated for use and contains durvalumab 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 Samsung Biologics Co., Ltd. on January 05, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Durvalumab is used to treat a certain type of bladder and urinary tract cancer. It is also used to treat lung cancer. It works by helping your immune system fight the cancer. This medication belongs to a class of drugs known as monoclonal antibodies.

How is this Samsung Biologics Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71124003000. 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)
71124-0030-0
11-Digit CMS (5-4-2)
71124-0030-00

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