BEXLUTRY

Product NDC
69945-177
11-digit product format
699450177
Labeler code
69945
Product ID
69945-177_5b8746b6-9986-11cc-e063-6394a90af38b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LUTETIUM OXODOTREOTIDE LU-177
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Curium US LLC
Application
NDA218525
Marketing category
NDA
Marketing start
2026-09-14
Substance
LUTETIUM OXODOTREOTIDE LU-177
Active strength
10 mCi/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
BEXLUTRY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUTETIUM OXODOTREOTIDE LU-17710 mCi/mL

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69945-177-016994501770120 mL in 1 VIAL, SINGLE-DOSE (69945-177-01) 20 ml2026-09-14NoNoCurrent