Evolocumab Injection, Solution
NDC Package 68225-080-00

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.

Evolocumab injection is evolocumab is used to help lower "bad" cholesterol (LDL) in the blood. This formulation utilizes a injection, solution delivery system. Marketed by Patheon Italia S.p.a., this product is identified by NDC 68225-080.

Identification & Billing

NDC Package Code
68225-080-00
Package Description
480 CARTRIDGE in 1 BOX / 3.5 mL in 1 CARTRIDGE
Product Code
68225-080
11-Digit Billing Format
68225008000

Clinical Specifications

Proprietary Name
Evolocumab
Non-Proprietary Name
Evolocumab
Substance Name
Evolocumab
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)
EVOLOCUMAB 420 mg/3.5mL
Usage Information
Evolocumab is used to help lower "bad" cholesterol (LDL) in the blood. For people who have high levels of LDL, it is used along with a proper diet, alone or other LDL-lowering treatments (such as "statin" drugs, ezetimibe, LDL apheresis). Evolocumab is also used by people who have heart disease to help prevent heart attacks and strokes. This medication belongs to a class of drugs known as monoclonal antibodies. It works by improving how well your body gets rid of LDL cholesterol. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Regulatory & Marketing

Labeler Name
Patheon Italia S.p.a.
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
08-01-2016
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 68225-080-00 identifies a specific commercial package of 480 cartridge in 1 box / 3.5 ml in 1 cartridge of Evolocumab (UNFINISHED drug), drug for further processing labeled by Patheon Italia S.p.a.. This injection, solution is formulated for use and contains evolocumab 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 Patheon Italia S.p.a. on August 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Evolocumab is used to help lower "bad" cholesterol (LDL) in the blood. For people who have high levels of LDL, it is used along with a proper diet, alone or other LDL-lowering treatments (such as "statin" drugs, ezetimibe, LDL apheresis). Evolocumab is also used by people who have heart disease to help prevent heart attacks and strokes. This medication belongs to a class of drugs known as monoclonal antibodies. It works by improving how well your body gets rid of LDL cholesterol. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

How is this Patheon Italia S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68225008000. 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)
68225-080-00
11-Digit CMS (5-4-2)
68225-0080-00

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