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  5. NDC Package Code: 46708-654-09 Icatibant

NDC Package 46708-654-09 Icatibant

Injection 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:
46708-654-09
Package Description:
3 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS
Product Code:
46708-654
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:
46708065409
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Alembic Pharmaceuticals Limited
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):
Sample Package:
No
FDA Application Number:
ANDA213773
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-14-2024
Listing Expiration Date:
12-31-2026
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
46708-654-031 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 46708-654-09?

The NDC Packaged Code 46708-654-09 is assigned to a package of 3 syringe, glass in 1 carton / 3 ml in 1 syringe, glass of Icatibant, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is injection and is administered via subcutaneous form.

Is NDC 46708-654 included in the NDC Directory?

Yes, Icatibant with product code 46708-654 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on June 14, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 46708-654-09?

The 11-digit format is 46708065409. 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
5-3-246708-654-095-4-246708-0654-09