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 ID: 0469-0420_034e698e-c634-4372-9a9a-89ca83dc0a80
• NDC: 0469-0420
• Product Type: Human Prescription Drug
• Proprietary Name: CRESEMBA
• Generic Name: Isavuconazonium Sulfate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-03-06
• Marketing Category: NDA / NDA
• Application Number: NDA207501
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: ISAVUCONAZONIUM SULFATE
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

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 Date: 2015-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-0420-99 [00469042099]

CRESEMBA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA207501
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-06

Drug Details

Active Ingredients

Ingredient	Strength
ISAVUCONAZONIUM SULFATE	74.4 mg/mL

OpenFDA Data

• SPL SET ID: 8f7f73b8-586a-4df0-935f-fecd4696c16c
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • 31Q44514JV
• 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"

NDC	Brand Name	Generic Name
0469-0420	CRESEMBA	isavuconazonium sulfate
0469-0520	CRESEMBA	isavuconazonium sulfate
0469-2860	CRESEMBA	isavuconazonium sulfate