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  5. NDC Package Code: 63833-828-02 Haegarda C1 Esterase Inhibitor Subcutaneous (human)

NDC Package 63833-828-02 Haegarda C1 Esterase Inhibitor Subcutaneous (human)

Human C1-esterase Inhibitor Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63833-828-02
Package Description:
1 KIT in 1 CARTON * 4 mL in 1 VIAL, SINGLE-USE (63833-838-01) * 4 mL in 1 VIAL, SINGLE-USE (63833-765-18)
Product Code:
63833-828
Proprietary Name:
Haegarda C1 Esterase Inhibitor Subcutaneous (human)
Non-Proprietary Name:
Human C1-esterase Inhibitor
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.
11-Digit NDC Billing Format:
63833082802
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1926818 - C1 esterase inhibitor (human) 2000 UNT Injection
  • RxCUI: 1926823 - HAEGARDA 2000 UNT Injection
  • RxCUI: 1926823 - C1 esterase inhibitor (human) 2000 UNT Injection [Haegarda]
  • RxCUI: 1926823 - Haegarda 2000 UNT Injection
  • RxCUI: 1926825 - C1 esterase inhibitor (human) 3000 UNT Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Csl Behring Gmbh
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125606
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-22-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63833-828-02?

    The NDC Packaged Code 63833-828-02 is assigned to a package of 1 kit in 1 carton * 4 ml in 1 vial, single-use (63833-838-01) * 4 ml in 1 vial, single-use (63833-765-18) of Haegarda C1 Esterase Inhibitor Subcutaneous (human), a plasma derivative labeled by Csl Behring Gmbh. The product's dosage form is kit and is administered via form.

    Is NDC 63833-828 included in the NDC Directory?

    Yes, Haegarda C1 Esterase Inhibitor Subcutaneous (human) with product code 63833-828 is active and included in the NDC Directory. The product was first marketed by Csl Behring Gmbh on June 22, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63833-828-02?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 63833-828-02?

    The 11-digit format is 63833082802. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263833-828-025-4-263833-0828-02