NDC Package 61434-002-09 Durvalumab Injection, Solution

Injection, Solution - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61434-002-09

Package Description:

288 VIAL in 1 CASE / 10 mL in 1 VIAL

Product Code:

61434-002

Non-Proprietary Name:

Durvalumab Injection, Solution

Substance Name:

Durvalumab

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.

11-Digit NDC Billing Format:

61434000209

Product Type:

Human Prescription Drug

Labeler Name:

Catalent Indiana, Llc

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 500 mg/10mL

Sample Package:

N/A

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:

05-01-2017

Listing Expiration Date:

12-31-2024

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

61434 - Catalent Indiana, Llc
- 61434-002 -
  - 61434-002-09 - 288 VIAL in 1 CASE / 10 mL in 1 VIAL

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61434-002-10	288 VIAL in 1 CASE / 10 mL in 1 VIAL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61434-002-09?

The NDC Packaged Code 61434-002-09 is assigned to an UNFINISHED drug package of 288 vial in 1 case / 10 ml in 1 vial of Durvalumab Injection, Solution, a human prescription drug labeled by Catalent Indiana, Llc. The product's dosage form is injection, solution and is administered via form.

Is NDC 61434-002 included in the NDC Directory?

Yes, Durvalumab Injection, Solution is an UNFINISHED PRODUCT with code 61434-002 that is active and included in the NDC Directory. The product was first marketed by Catalent Indiana, Llc on May 01, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61434-002-09?

The 11-digit format is 61434000209. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61434-002-09	5-4-2	61434-0002-09

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