Bexlutry Injection
NDC Package 69945-177-01

11-digit billing NDC: 69945017701
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bexlutry (lutetium oxodotreotide lu-177) injection is bEXLUTRY is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. This formulation utilizes a injection delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-177 and is authorized under FDA application NDA218525.

Identification & Billing

NDC Package Code
69945-177-01
Package Description
20 mL in 1 VIAL, SINGLE-DOSE
Product Code
69945-177
11-Digit Billing Format
69945017701

Clinical Specifications

Proprietary Name
Bexlutry
Non-Proprietary Name
Lutetium Oxodotreotide Lu-177
Substance Name
Lutetium Oxodotreotide Lu-177
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LUTETIUM OXODOTREOTIDE LU-177 10 mCi/mL
Usage Information
BEXLUTRY is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA218525
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-14-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69945-177-01 identifies a specific commercial package of 20 ml in 1 vial, single-dose of Bexlutry, a human prescription drug labeled by Curium Us Llc. This injection is formulated for intravenous use and contains lutetium oxodotreotide lu-177 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Curium Us Llc on September 14, 2026. The current certification is valid through December 31, 2027.

How is this Curium Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69945017701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69945-177-01
11-Digit CMS (5-4-2)
69945-0177-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.