Package 0078-1217-61
Brand: pluvicto
Generic: lutetium lu 177 vipivotide tetraxetanPackage Facts
Identity
Package NDC
0078-1217-61
Digits Only
0078121761
Product NDC
0078-1217
Description
1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
pluvicto
Generic
lutetium lu 177 vipivotide tetraxetan
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "14908037-2892-4d98-a053-253ce35afb1a", "openfda": {"nui": ["N0000194017", "N0000194016"], "unii": ["G6UF363ECX"], "rxcui": ["2597057", "2597060"], "spl_set_id": ["14908037-2892-4d98-a053-253ce35afb1a"], "pharm_class_epc": ["Radioligand Therapeutic Agent [EPC]"], "pharm_class_moa": ["Radioligand Activity [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS", "package_ndc": "0078-1217-61", "marketing_start_date": "20260115"}], "brand_name": "PLUVICTO", "product_id": "0078-1217_14908037-2892-4d98-a053-253ce35afb1a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioligand Activity [MoA]", "Radioligand Therapeutic Agent [EPC]"], "product_ndc": "0078-1217", "generic_name": "lutetium Lu 177 vipivotide tetraxetan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PLUVICTO", "active_ingredients": [{"name": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN", "strength": "27 mCi/mL"}], "application_number": "NDA215833", "marketing_category": "NDA", "marketing_start_date": "20220323", "listing_expiration_date": "20271231"}