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  5. NDC Package Code: 69097-664-34 Icatibant

NDC Package 69097-664-34 Icatibant

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
69097-664-34
Package Description:
1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
Product Code:
69097-664
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:
69097066434
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:
    Cipla Usa Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    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:
    ANDA212446
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-13-2020
    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 69097-664-34 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    69097066434J1744Icatibant injection1 MG313030

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    69097-664-683 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69097-664-34?

    The NDC Packaged Code 69097-664-34 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 Cipla Usa Inc.. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 69097-664 included in the NDC Directory?

    Yes, Icatibant with product code 69097-664 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on July 13, 2020 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 69097-664-34?

    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 69097-664-34?

    The 11-digit format is 69097066434. 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
    5-3-269097-664-345-4-269097-0664-34