CRESEMBA
- Product NDC
- 0469-0420
- 11-digit product format
- 004690420
- Labeler code
- 0469
- Product ID
- 0469-0420_7e6e45d4-9266-4451-b6b6-0d054bbcab63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isavuconazonium sulfate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Astellas Pharma US, Inc.
- Application
- NDA207501
- Marketing category
- NDA
- Marketing start
- 2015-03-06
- Substance
- ISAVUCONAZONIUM SULFATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CRESEMBA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISAVUCONAZONIUM SULFATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31Q44514JV |
| Rxcui | 1608327, 1608333, 1608811, 1608815, 2623470, 2623472 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0469-0420-01 | CRESEMBA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 21 |
| 0469-0420-01 | CRESEMBA | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISAVUCONAZONIUM SULFATE | ACTIVE INGREDIENT | 31Q44514JV | CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 5 | |
| ISAVUCONAZOLE | ACTIVE MOIETY | 60UTO373KE | CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0469-0420 | CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20250503_8f7f73b8-586a-4df0-935f-fecd4696c16c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0469-0420-01 | 00469042001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE | | 2015-03-06 | 0000-00-00 | No | No | Current |
| 0469-0420-99 | 00469042099 | 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 | 10 carton | 2015-03-06 | 0000-00-00 | No | No | Current |