Alirocumab Injection, Solution
NDC Package 61755-921-00

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.

Alirocumab injection is alirocumab is used by people who have blockage in the heart blood vessels to reduce the risk of heart attack, stroke, and certain types of chest pain that require treatment in a hospital. This formulation utilizes a injection, solution delivery system. Marketed by Regeneron Pharmaceuticals, Inc, this product is identified by NDC 61755-921.

Identification & Billing

NDC Package Code
61755-921-00
Package Description
5000 mL in 1 BOTTLE
Product Code
61755-921
11-Digit Billing Format
61755092100

Clinical Specifications

Proprietary Name
Alirocumab
Non-Proprietary Name
Alirocumab
Substance Name
Alirocumab
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)
ALIROCUMAB 150 mg/mL
Usage Information
Alirocumab is used by people who have blockage in the heart blood vessels to reduce the risk of heart attack, stroke, and certain types of chest pain that require treatment in a hospital. It is also used by people who have an inherited condition that causes high levels of LDL. Treatment with alirocumab, a proper diet, and cholesterol-lowering drugs can help lower "bad" cholesterol (LDL) in the blood. Alirocumab 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
Regeneron Pharmaceuticals, Inc
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
07-24-2015
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 61755-921-00 identifies a specific commercial package of 5000 ml in 1 bottle of Alirocumab (UNFINISHED drug), drug for further processing labeled by Regeneron Pharmaceuticals, Inc. This injection, solution is formulated for use and contains alirocumab 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 Regeneron Pharmaceuticals, Inc on July 24, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Alirocumab is used by people who have blockage in the heart blood vessels to reduce the risk of heart attack, stroke, and certain types of chest pain that require treatment in a hospital. It is also used by people who have an inherited condition that causes high levels of LDL. Treatment with alirocumab, a proper diet, and cholesterol-lowering drugs can help lower "bad" cholesterol (LDL) in the blood. Alirocumab 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 Regeneron Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61755092100. 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)
61755-921-00
11-Digit CMS (5-4-2)
61755-0921-00

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