BEXLUTRY

Product NDC: 69945-177
11-digit product format: 699450177
Labeler code: 69945
Product ID: 69945-177_5ebf07f8-62f6-fd90-e063-6294a90ac739
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lutetium Lu 177 dotatate
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 · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218525-001	BEXLUTRY	LUTETIUM LU-177 DOTATATE	10mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2026-09-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N218525-001	BEXLUTRY	10mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2026-09-14	`c2088c7a36db…`

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
Ingredient	Strength
LUTETIUM OXODOTREOTIDE LU-177	10 mCi/mL

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AE221IM3BB	LUTETIUM OXODOTREOTIDE LU-177	437608-50-9	LUTETIUM OXODOTREOTIDE LU-177

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69945-177-01	69945017701	20 mL in 1 VIAL, SINGLE-DOSE (69945-177-01)	20 ml	2026-09-14	No	No	Current