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  5. NDC Package Code: 60505-6214-1 Icatibant

NDC Package 60505-6214-1 Icatibant

Icatibant Acetate Injection, Solution Subcutaneous - 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:
60505-6214-1
Package Description:
1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
Product Code:
60505-6214
Proprietary Name:
Icatibant
Non-Proprietary Name:
Icatibant Acetate
Substance Name:
Icatibant Acetate
Usage Information:
Icatibant is used to treat sudden attacks of a certain immune system condition passed down through families called hereditary angioedema (HAE). Although this medication is not a cure for HAE, icatibant may lessen the symptoms of an attack such as rapid swelling and pain of the hands, arms, feet, legs, face, tongue, and upper airway. When attacks involve the stomach/intestines, symptoms may include abdominal pain/cramps, diarrhea, constipation, or vomiting. Attacks may happen at any time. However, stress, injury, or illness may trigger attacks in some people. Icatibant works by blocking the action of a natural substance in the body called bradykinin. Bradykinin is thought to cause the symptoms of an HAE attack.
11-Digit NDC Billing Format:
60505621401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1148141 - icatibant 30 MG in 3 ML Prefilled Syringe
  • RxCUI: 1148141 - 3 ML icatibant 10 MG/ML Prefilled Syringe
  • RxCUI: 1148141 - icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Apotex Corp.
    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):
  • ICATIBANT ACETATE 30 mg/3mL
    • Pharmacologic Class(es):
  • Bradykinin B2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Bradykinin B2 Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212081
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-15-2021
    Listing Expiration Date:
    12-31-2025
    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 60505-6214-1?

    The NDC Packaged Code 60505-6214-1 is assigned to a package of 1 syringe, glass in 1 carton / 3 ml in 1 syringe, glass of Icatibant, a human prescription drug labeled by Apotex Corp.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 60505-6214 included in the NDC Directory?

    Yes, Icatibant with product code 60505-6214 is active and included in the NDC Directory. The product was first marketed by Apotex Corp. on April 15, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 60505-6214-1?

    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 60505-6214-1?

    The 11-digit format is 60505621401. 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 5-4-1 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
    5-4-160505-6214-15-4-260505-6214-01