NDC 0469-2860

CRESEMBA

Isavuconazonium Sulfate

CRESEMBA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Isavuconazonium Sulfate.

• Product ID: 0469-2860_4b90b7b7-03d3-4031-9a20-d9fed2eeb045
• NDC: 0469-2860
• Product Type: Human Prescription Drug
• Proprietary Name: CRESEMBA
• Generic Name: Isavuconazonium Sulfate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2022-11-22
• Marketing Category: NDA /
• Application Number: NDA207500
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: ISAVUCONAZONIUM SULFATE
• Active Ingredient Strength: 40 mg/1
• 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 0469-2860-35

35 BLISTER PACK in 1 CARTON (0469-2860-35) > 1 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2022-11-22
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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