Package 69488-010-61

Brand: pluvicto

Generic: lutetium lu 177 vipivotide tetraxetan
NDC Package

Package Facts

Identity

Package NDC 69488-010-61
Digits Only 6948801061
Product NDC 69488-010
Description

1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS

Marketing

Marketing Status
Marketed Since 2022-03-23
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": "b5fa3f83-d3c8-446e-8e65-9039e274277f", "openfda": {"nui": ["N0000194017", "N0000194016"], "unii": ["G6UF363ECX"], "rxcui": ["2597057", "2597060"], "spl_set_id": ["fb973a8d-7fea-4a7a-963f-2a8e67a46e55"], "pharm_class_epc": ["Radioligand Therapeutic Agent [EPC]"], "pharm_class_moa": ["Radioligand Activity [MoA]"], "manufacturer_name": ["Advanced Accelerator Applications USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 PACKAGE (69488-010-61)  / 7.5 mL in 1 VIAL, GLASS", "package_ndc": "69488-010-61", "marketing_start_date": "20220323"}], "brand_name": "PLUVICTO", "product_id": "69488-010_b5fa3f83-d3c8-446e-8e65-9039e274277f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioligand Activity [MoA]", "Radioligand Therapeutic Agent [EPC]"], "product_ndc": "69488-010", "generic_name": "lutetium Lu 177 vipivotide tetraxetan", "labeler_name": "Advanced Accelerator Applications USA, Inc", "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": "20261231"}