Emicizumab Solution
NDC Package 71124-0010-0

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.

Emicizumab solution is a drug for further processing. This formulation utilizes a solution delivery system. Marketed by Samsung Biologics Co., Ltd., this product is identified by NDC 71124-0010.

Identification & Billing

NDC Package Code
71124-0010-0
Package Description
1 SOLUTION in 1 VIAL, SINGLE-USE
Product Code
71124-0010
11-Digit Billing Format
71124001000

Clinical Specifications

Proprietary Name
Emicizumab
Non-Proprietary Name
Emicizumab
Substance Name
Emicizumab
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)
EMICIZUMAB 60 mg/1

Regulatory & Marketing

Labeler Name
Samsung Biologics Co., Ltd.
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
08-16-2018
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 71124-0010-0 identifies a specific commercial package of 1 solution in 1 vial, single-use of Emicizumab (UNFINISHED drug), drug for further processing labeled by Samsung Biologics Co., Ltd.. This solution is formulated for use and contains emicizumab 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 Samsung Biologics Co., Ltd. on August 16, 2018. The current certification is valid through December 31, 2026.

How is this Samsung Biologics Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71124001000. 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)
71124-0010-0
11-Digit CMS (5-4-2)
71124-0010-00

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