Package 0469-0420-01
Brand: cresemba
Generic: isavuconazonium sulfatePackage Facts
Identity
Package NDC
0469-0420-01
Digits Only
0469042001
Product NDC
0469-0420
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
cresemba
Generic
isavuconazonium sulfate
Sample Package
No
Linked Drug Pages (1)
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"}