NDC 0469-0420

CRESEMBA

Isavuconazonium Sulfate

CRESEMBA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Isavuconazonium Sulfate.

Product ID0469-0420_034e698e-c634-4372-9a9a-89ca83dc0a80
NDC0469-0420
Product TypeHuman Prescription Drug
Proprietary NameCRESEMBA
Generic NameIsavuconazonium Sulfate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-03-06
Marketing CategoryNDA / NDA
Application NumberNDA207501
Labeler NameAstellas Pharma US, Inc.
Substance NameISAVUCONAZONIUM SULFATE
Active Ingredient Strength40 mg/mL
Pharm ClassesAzole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0469-0420-99

10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0469-0420-99 [00469042099]

CRESEMBA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA207501
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-06

Drug Details

Active Ingredients

IngredientStrength
ISAVUCONAZONIUM SULFATE74.4 mg/mL

OpenFDA Data

SPL SET ID:8f7f73b8-586a-4df0-935f-fecd4696c16c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1608333
  • 1608327
  • 1608811
  • 1608815
  • Pharmacological Class

    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Azole Antifungal [EPC]

    NDC Crossover Matching brand name "CRESEMBA" or generic name "Isavuconazonium Sulfate"

    NDCBrand NameGeneric Name
    0469-0420CRESEMBAisavuconazonium sulfate
    0469-0520CRESEMBAisavuconazonium sulfate
    0469-2860CRESEMBAisavuconazonium sulfate

    Trademark Results [CRESEMBA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CRESEMBA
    CRESEMBA
    87380656 5363262 Live/Registered
    Astellas US LLC
    2017-03-22
    CRESEMBA
    CRESEMBA
    85967909 4532336 Live/Registered
    Astellas Pharma Inc.
    2013-06-24

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