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  5. NDC Package Code: 47783-101-01 Kalbitor

NDC Package 47783-101-01 Kalbitor

Ecallantide Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
47783-101-01
Package Description:
3 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS
Product Code:
47783-101
Proprietary Name:
Kalbitor
Non-Proprietary Name:
Ecallantide
Substance Name:
Ecallantide
Usage Information:
This medication is used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). Ecallantide blocks a natural substance produced by the body (kallikrein) which acts to increase amounts of another natural substance (bradykinin) thought to cause the symptoms seen during an acute attack of HAE. This medication does not cure HAE. Ecallantide may lessen the symptoms during an acute attack of HAE such as rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat. When attacks involve the intestines, symptoms may include abdominal pain/cramps, diarrhea or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people.
11-Digit NDC Billing Format:
47783010101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 884698 - ecallantide 10 MG in 1 mL Injection
  • RxCUI: 884698 - 1 ML ecallantide 10 MG/ML Injection
  • RxCUI: 884698 - ecallantide 10 MG per 1 ML Injection
  • RxCUI: 884702 - Kalbitor 10 MG in 1 mL Injection
  • RxCUI: 884702 - 1 ML ecallantide 10 MG/ML Injection [Kalbitor]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Takeda Pharmaceuticals America, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • ECALLANTIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Kallikrein Inhibitors - [MoA] (Mechanism of Action)
  • Plasma Kallikrein Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125277
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-02-2010
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 47783-101-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    47783010101J1290Ecallantide injection1 MG131030

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47783-101-01?

    The NDC Packaged Code 47783-101-01 is assigned to a package of 3 vial, glass in 1 carton / 1 ml in 1 vial, glass of Kalbitor, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 47783-101 included in the NDC Directory?

    Yes, Kalbitor with product code 47783-101 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on February 02, 2010 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 47783-101-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 47783-101-01?

    The 11-digit format is 47783010101. 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
    5-3-247783-101-015-4-247783-0101-01