Durvalumab Solution
NDC Package 12714-087-01

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 solution is durvalumab is used to treat a certain type of bladder and urinary tract cancer. This formulation utilizes a solution delivery system. Marketed by Boehringer Ingelheim Pharma Gmbh And Co. Kg, this product is identified by NDC 12714-087.

Identification & Billing

NDC Package Code
12714-087-01
Package Description
50 mg in 1 TANK
Product Code
12714-087
11-Digit Billing Format
12714008701

Clinical Specifications

Proprietary Name
Durvalumab
Non-Proprietary Name
Durvalumab
Substance Name
Durvalumab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
DURVALUMAB 50 mg/50mg
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
Boehringer Ingelheim Pharma Gmbh And Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2024
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 12714-087-01 identifies a specific commercial package of 50 mg in 1 tank of Durvalumab (UNFINISHED drug), a bulk ingredient labeled by Boehringer Ingelheim Pharma Gmbh And Co. Kg. This 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 Boehringer Ingelheim Pharma Gmbh And Co. Kg on January 01, 2024. 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 Boehringer Ingelheim Pharma Gmbh And Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12714008701. 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)
12714-087-01
11-Digit CMS (5-4-2)
12714-0087-01

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