NDC Package 0469-0420-01 Cresemba

Isavuconazonium Sulfate Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
0469-0420-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
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:
00469042001
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:
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.
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:
12-31-2026
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.

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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 0469-0420-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00469042001J1833Inj, isavuconazonium sulfate1 MG11372372

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0469-0420-01?

The NDC Packaged Code 0469-0420-01 is assigned to a package of 1 vial, single-dose in 1 carton / 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, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0469-0420-01?

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 0469-0420-01?

The 11-digit format is 00469042001. 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
4-4-20469-0420-015-4-200469-0420-01