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  5. NDC Package Code: 0469-0420-99 Cresemba

NDC Package 0469-0420-99 Cresemba

Isavuconazonium Sulfate Injection, Powder, Lyophilized, For Solution Intravenous - 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:
0469-0420-99
Package Description:
10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0469-0420
Proprietary Name:
Cresemba
Non-Proprietary Name:
Isavuconazonium Sulfate
Substance Name:
Isavuconazonium Sulfate
Usage Information:
This medication is used to treat certain serious fungal infections. This medication is known as an azole antifungal. It works by stopping the growth of fungi.
11-Digit NDC Billing Format:
00469042099
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1608327 - isavuconazonium sulfate 186 MG Oral Capsule
  • RxCUI: 1608327 - isavuconazonium sulfate 186 MG (isavuconazole 100 MG) Oral Capsule
  • RxCUI: 1608333 - Cresemba 186 MG Oral Capsule
  • RxCUI: 1608333 - isavuconazonium sulfate 186 MG Oral Capsule [Cresemba]
  • RxCUI: 1608333 - Cresemba 186 MG (isavuconazole 100 MG) Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astellas Pharma Us, Inc.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ISAVUCONAZONIUM SULFATE 40 mg/mL
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA207501
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-06-2015
    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.

    Frequently Asked Questions

    What is NDC 0469-0420-99?

    The NDC Packaged Code 0469-0420-99 is assigned to a package of 10 carton in 1 carton / 1 vial, single-dose in 1 carton (0469-0420-01) / 5 ml in 1 vial, single-dose of Cresemba, a human prescription drug labeled by Astellas Pharma Us, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0469-0420 included in the NDC Directory?

    Yes, Cresemba with product code 0469-0420 is active and included in the NDC Directory. The product was first marketed by Astellas Pharma Us, Inc. on March 06, 2015 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 0469-0420-99?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0469-0420-99?

    The 11-digit format is 00469042099. 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
    4-4-20469-0420-995-4-200469-0420-99