PLUVICTO
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO. PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
fb973a8d-7fea-4a7a-963f-2a8e67a46e55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Advanced Accelerator Applications USA, Inc
DUNS: 051714355
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lutetium Lu 177 vipivotide tetraxetan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69488-010
Application NumberNDA215833
Product Classification
M
Marketing Category
C73594
G
Generic Name
lutetium Lu 177 vipivotide tetraxetan
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2022
FDA Product Classification
INGREDIENTS (7)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
GENTISIC ACIDInactive
Code: VP36V95O3T
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
PENTETIC ACIDInactive
Code: 7A314HQM0I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LUTETIUM LU-177 VIPIVOTIDE TETRAXETANActive
Quantity: 27 mCi in 1 mL
Code: G6UF363ECX
Classification: ACTIB