Haegarda Kit
NDC Package 63833-829-02

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

Package Information

Haegarda (human c1-esterase inhibitor) kits is a medication used to help prevent swelling and painful attacks caused by a certain inherited disease (hereditary angioedema-HAE). This formulation utilizes a kit delivery system. Marketed by Csl Behring Gmbh, this product is identified by NDC 63833-829 and is authorized under FDA application BLA125606.

Identification & Billing

NDC Package Code
63833-829-02
Package Description
1 KIT in 1 CARTON * 5.6 mL in 1 VIAL, SINGLE-USE (63833-839-01) * 5.6 mL in 1 VIAL, SINGLE-USE (63833-765-19)
Product Code
63833-829
11-Digit Billing Format
63833082902
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Haegarda C1 Esterase Inhibitor Subcutaneous (human)
Non-Proprietary Name
Human C1-esterase Inhibitor
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to help prevent swelling and painful attacks caused by a certain inherited disease (hereditary angioedema-HAE). Most people with this disease have too little of a certain substance produced by your body (C1-esterase inhibitor). Some people with this disease have normal amounts of the substance, but it doesn't work right. Anxiety, stress, illness, or surgery may trigger attacks in some people. Symptoms such as rapid swelling of the hands, feet, limbs, face, tongue, or throat can occur. Swelling of the belly may cause symptoms such as severe pain, nausea, vomiting, or diarrhea. This medication works by increasing the amount of C1-esterase inhibitor in your body. This medication should not be used to treat sudden swelling attacks caused by HAE. Ask your doctor ahead of time what to do if you have a sudden attack.

Regulatory & Marketing

Labeler Name
Csl Behring Gmbh
Product Type
Plasma Derivative
FDA Application #
BLA125606
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-22-2017
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 63833-829-02 identifies a specific commercial package of 1 kit in 1 carton * 5.6 ml in 1 vial, single-use (63833-839-01) * 5.6 ml in 1 vial, single-use (63833-765-19) of Haegarda C1 Esterase Inhibitor Subcutaneous (human), a plasma derivative labeled by Csl Behring Gmbh. This kit is formulated for use and contains 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 Csl Behring Gmbh on June 22, 2017. 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 and painful attacks caused by a certain inherited disease (hereditary angioedema-HAE). Most people with this disease have too little of a certain substance produced by your body (C1-esterase inhibitor). Some people with this disease have normal amounts of the substance, but it doesn't work right. Anxiety, stress, illness, or surgery may trigger attacks in some people. Symptoms such as rapid swelling of the hands, feet, limbs, face, tongue, or throat can occur. Swelling of the belly may cause symptoms such as severe pain, nausea, vomiting, or diarrhea. This medication works by increasing the amount of C1-esterase inhibitor in your body. This medication should not be used to treat sudden swelling attacks caused by HAE. Ask your doctor ahead of time what to do if you have a sudden attack.

How is this Csl Behring Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63833082902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
63833-829-02
11-Digit CMS (5-4-2)
63833-0829-02

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