Berinert Kit
NDC Package 63833-825-02

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

Package Information

Berinert (human c1-esterase inhibitor) kits is a medication used to treat the swelling problems that occur with a certain immune disease passed down through families (hereditary angioedema-HAE). This formulation utilizes a kit delivery system. Marketed by Csl Behring Gmbh, this product is identified by NDC 63833-825 and is authorized under FDA application BLA125287.

Identification & Billing

NDC Package Code
63833-825-02
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL (63833-835-01) * 10 mL in 1 VIAL (63833-765-15)
Product Code
63833-825
11-Digit Billing Format
63833082502
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Berinert
Non-Proprietary Name
Human C1-esterase Inhibitor
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat the 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 treat attacks of sudden swelling due to hereditary angioedema.

Regulatory & Marketing

Labeler Name
Csl Behring Gmbh
Product Type
Plasma Derivative
FDA Application #
BLA125287
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-22-2011
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0597
Source: ASP
C-1 esterase, berinert
HCPCS Dosage 10 UNITS
Units / Pkg 50

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 63833-825-02 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial (63833-835-01) * 10 ml in 1 vial (63833-765-15) of Berinert, 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 December 22, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat the 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 treat attacks of sudden swelling due to hereditary angioedema.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63833082502. 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)
63833-825-02
11-Digit CMS (5-4-2)
63833-0825-02

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