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  5. NDC Package Code: 0093-3066-34 Icatibant

NDC Package 0093-3066-34 Icatibant

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

Table of Contents

    1. Package Information
    2. Other Packages
    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:
0093-3066-34
Package Description:
1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE
Product Code:
0093-3066
Proprietary Name:
Icatibant
Non-Proprietary Name:
Icatibant
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:
00093306634
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:
    Teva Pharmaceuticals Usa, 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):
  • ICATIBANT ACETATE 10 mg/mL
    • 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:
    ANDA210118
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-15-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0093-3066-933 CARTON in 1 BOX / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0093-3066-34?

    The NDC Packaged Code 0093-3066-34 is assigned to a package of 1 syringe in 1 carton / 3 ml in 1 syringe of Icatibant, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 0093-3066 included in the NDC Directory?

    Yes, Icatibant with product code 0093-3066 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on July 15, 2019 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 0093-3066-34?

    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 0093-3066-34?

    The 11-digit format is 00093306634. 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 4-4-2 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
    4-4-20093-3066-345-4-200093-3066-34