Prescription drug · NDA
Cresemba (Isavuconazonium sulfate) NDC 0469-2860
Isavuconazonium sulfate 40 mg/1 · Capsule · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-2860-35 | 0046928603500469286035 | 7 BLISTER PACK in 1 CARTON (0469-2860-35) / 5 CAPSULE in 1 BLISTER PACKMarketed from Nov 22, 2022 |
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 — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.NDC labeler code 0469
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207500
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0469-2860_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
N400469286035followed by a unit qualifier and the quantityPackage 00469-2860-35. 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 .
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.
About NDC 0469-2860
- What is NDC 0469-2860?
- 0469-2860 is the product NDC for Cresemba (isavuconazonium sulfate), Isavuconazonium sulfate 40 mg/1 capsule, listed with the FDA by Astellas Pharma US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cresemba (Isavuconazonium sulfate).
- What is the active ingredient?
- Isavuconazonium sulfate.
- Who is the labeler?
- Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cresemba?
- 2 other product NDCs are listed under this name. See all Cresemba NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cresemba products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cresembaisavuconazonium sulfate | Isavuconazonium sulfate 100 mg/1 | CapsuleOral | Astellas Pharma US, Inc. | 0469-0520 | 00469-0520-02 |
| Cresembaisavuconazonium sulfate | Isavuconazonium sulfate 40 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Astellas Pharma US, Inc. | 0469-0420 | 00469-0420-01 |
Other NDCs under NDA 207500
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cresembaisavuconazonium sulfate | Isavuconazonium sulfate 100 mg/1 | CapsuleOral | Astellas Pharma US, Inc. | 0469-0520 |