Cinryze Injection, Powder, Lyophilized, For Solution
NDC Package 42227-081-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cinryze (human c1-esterase inhibitor) injection is a medication used to help prevent swelling problems that occur with a certain immune disease passed down through families (hereditary angioedema-HAE). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 42227-081 and is authorized under FDA application BLA125267.

Identification & Billing

NDC Package Code
42227-081-01
Package Description
5 mL in 1 VIAL, SINGLE-USE
Product Code
42227-081
11-Digit Billing Format
42227008101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cinryze
Non-Proprietary Name
Human C1-esterase Inhibitor
Substance Name
Human C1-esterase Inhibitor
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL
Pharmacologic Class
Usage Information
This medication is used to help prevent swelling problems that occur with a certain immune disease passed down through families (hereditary angioedema-HAE). HAE is caused by low levels or improper function of a natural substance produced by the body (C1-inhibitor). Symptoms such as rapid swelling of the hands, feet, limbs, face, tongue, or throat can occur. Swelling of the intestinal tract may cause symptoms such as abdominal cramps, diarrhea, or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people. This medication increases the level of C1-inhibitor to help prevent attacks of sudden swelling due to hereditary angioedema.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125267
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-01-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 42227-081-01 identifies a specific commercial package of 5 ml in 1 vial, single-use of Cinryze, a plasma derivative labeled by Takeda Pharmaceuticals America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains human c1-esterase inhibitor 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 Takeda Pharmaceuticals America, Inc. on December 01, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to help prevent swelling problems that occur with a certain immune disease passed down through families (hereditary angioedema-HAE). HAE is caused by low levels or improper function of a natural substance produced by the body (C1-inhibitor). Symptoms such as rapid swelling of the hands, feet, limbs, face, tongue, or throat can occur. Swelling of the intestinal tract may cause symptoms such as abdominal cramps, diarrhea, or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people. This medication increases the level of C1-inhibitor to help prevent attacks of sudden swelling due to hereditary angioedema.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42227008101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
42227-081-01
11-Digit CMS (5-4-2)
42227-0081-01

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