Durvalumab Injection, Solution
NDC Package 17228-4500-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 injection is durvalumab is used to treat a certain type of bladder and urinary tract cancer. This formulation utilizes a injection, solution delivery system. Marketed by Astrazeneca Ab, this product is identified by NDC 17228-4500.

Identification & Billing

NDC Package Code
17228-4500-2
Package Description
330 VIAL in 1 TRAY / 2.4 mL in 1 VIAL
Product Code
17228-4500
11-Digit Billing Format
17228450002

Clinical Specifications

Proprietary Name
Durvalumab
Non-Proprietary Name
Durvalumab
Substance Name
Durvalumab
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.
Active Ingredient(s)
DURVALUMAB 120 mg/2.4mL
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
Astrazeneca Ab
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17228-4500). Click a package code to view its specific billing and regulatory data.

17228-4500-1
330 VIAL in 1 TRAY / 2.4 mL in 1 VIAL

* 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 17228-4500-2 identifies a specific commercial package of 330 vial in 1 tray / 2.4 ml in 1 vial of Durvalumab (UNFINISHED drug), drug for further processing labeled by Astrazeneca Ab. This injection, solution 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 Astrazeneca Ab on January 01, 2020. 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 Astrazeneca Ab product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17228450002. 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)
17228-4500-2
11-Digit CMS (5-4-2)
17228-4500-02

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