PLUVICTO

Product NDC
69488-010
11-digit product format
694880010
Labeler code
69488
Product ID
69488-010_778126c6-8402-4888-bec9-24ed4eba816f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lutetium Lu 177 vipivotide tetraxetan
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Advanced Accelerator Applications USA, Inc
Application
NDA215833
Marketing category
NDA
Marketing start
2022-03-23
Marketing end
0000-00-00
Substance
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Active strength
27 mCi/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69488-010-61EA - Each69488-010ac051eca-1322-4518-9525-5eed232fd89f12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69488-010PLUVICTO (LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN) INJECTION, SOLUTION [ADVANCED ACCELERATOR APPLICATIONS USA, INC]9Legacy NDC20250331_fb973a8d-7fea-4a7a-963f-2a8e67a46e55.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69488-010-61694880010611 VIAL, GLASS in 1 PACKAGE (69488-010-61) > 7.5 mL in 1 VIAL, GLASS2022-03-230000-00-00NoNoCurrent