cresemba

Generic: isavuconazonium sulfate

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cresemba
Generic Name isavuconazonium sulfate
Labeler astellas pharma us, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

isavuconazonium sulfate 40 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-0420
Product ID 0469-0420_7e6e45d4-9266-4451-b6b6-0d054bbcab63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207501
Listing Expiration 2026-12-31
Marketing Start 2015-03-06

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs] cytochrome p450 3a4 inhibitors [moa] organic cation transporter 2 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04690420
Hyphenated Format 0469-0420

Supplemental Identifiers

RxCUI
1608327 1608333 1608811 1608815 2623470 2623472
UNII
31Q44514JV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cresemba (source: ndc)
Generic Name isavuconazonium sulfate (source: ndc)
Application Number NDA207501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0469-0420-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

isavuconazonium sulfate (40 mg/mL)

Linked Drug Pages (1)

CRESEMBA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7e6e45d4-9266-4451-b6b6-0d054bbcab63", "openfda": {"unii": ["31Q44514JV"], "rxcui": ["1608327", "1608333", "1608811", "1608815", "2623470", "2623472"], "spl_set_id": ["8f7f73b8-586a-4df0-935f-fecd4696c16c"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0469-0420-01", "marketing_start_date": "20150306"}], "brand_name": "CRESEMBA", "product_id": "0469-0420_7e6e45d4-9266-4451-b6b6-0d054bbcab63", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0469-0420", "generic_name": "isavuconazonium sulfate", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CRESEMBA", "active_ingredients": [{"name": "ISAVUCONAZONIUM SULFATE", "strength": "40 mg/mL"}], "application_number": "NDA207501", "marketing_category": "NDA", "marketing_start_date": "20150306", "listing_expiration_date": "20261231"}