pluvicto

Generic: lutetium lu 177 vipivotide tetraxetan

Labeler: advanced accelerator applications usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pluvicto
Generic Name lutetium lu 177 vipivotide tetraxetan
Labeler advanced accelerator applications usa, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lutetium lu-177 vipivotide tetraxetan 27 mCi/mL

Manufacturer
Advanced Accelerator Applications USA, Inc

Identifiers & Regulatory

Product NDC 69488-010
Product ID 69488-010_b5fa3f83-d3c8-446e-8e65-9039e274277f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215833
Listing Expiration 2026-12-31
Marketing Start 2022-03-23

Pharmacologic Class

Established (EPC)
radioligand therapeutic agent [epc]
Mechanism of Action
radioligand activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69488010
Hyphenated Format 69488-010

Supplemental Identifiers

RxCUI
2597057 2597060
UNII
G6UF363ECX
NUI
N0000194017 N0000194016

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 pluvicto (source: ndc)
Generic Name lutetium lu 177 vipivotide tetraxetan (source: ndc)
Application Number NDA215833 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 27 mCi/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

lutetium lu-177 vipivotide tetraxetan (27 mCi/mL)

Linked Drug Pages (1)

PLUVICTO ndc-match (0.9)

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"}