NDC product

CRESEMBA

NDC 0469-2860 · Astellas Pharma US, Inc.

Key facts

Product NDC 0469-2860
Proprietary name CRESEMBA
Nonproprietary name isavuconazonium sulfate
Substances ISAVUCONAZONIUM SULFATE
Dosage form CAPSULE
Route ORAL
Labeler Astellas Pharma US, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA207500
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
Marketing start Nov 22, 2022
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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