Cresemba (isavuconazonium sulfate) NDC 0469-0520

NDC codes

FDA NDC Directory

Product NDC (as listed)0469-0520Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00469-0520Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0469-0520-02	00469052002	2 BLISTER PACK in 1 CARTON (0469-0520-02) / 7 CAPSULE in 1 BLISTER PACKMarketed from Nov 4, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cresemba
Generic name (nonproprietary): isavuconazonium sulfate
Active ingredients: Isavuconazonium sulfate — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Astellas Pharma US, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 207500
Marketing start: Nov 4, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0469-0520_7e6e45d4-9266-4451-b6b6-0d054bbcab63SPL ID 7e6e45d4-9266-4451-b6b6-0d054bbcab63SPL set ID 8f7f73b8-586a-4df0-935f-fecd4696c16cRxCUI 1608327, 1608333, 1608811, 1608815, 2623470, 2623472UNII 31Q44514JV
Pharmacologic class: Azole Antifungal

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400469052002 followed by a unit qualifier and the quantity

Package 00469-0520-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 25, 2025.

Indications (excerpt from the label)

CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis ( 1.1 ) and Invasive mucormycosis ( 1.2 ) as follows: • CRESEMBA for injection : adults and pediatric patients 1 year of age and older • CRESEMBA capsules : adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater 1.1 Invasive Aspergillosis CRESEMBA ® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection : adults and pediatric patients 1 year of age and older [see Clinical Studies ( 14.1 ) and Clinical Pharmacology ( 12.4 )] CRESEMBA capsules : adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 207500

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 207500
Product	Strength	Form · route	Labeler	Product NDC
Cresembaisavuconazonium sulfate	Isavuconazonium sulfate 40 mg/1	CapsuleOral	Astellas Pharma US, Inc.	0469-2860