Lutathera Injection
NDC Package 69488-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Lutathera (lutetium lu 177 dotatate) injection is lUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. This formulation utilizes a injection delivery system. Marketed by Advanced Accelerator Applications Usa, Inc, this product is identified by NDC 69488-003 and is authorized under FDA application NDA208700.

Identification & Billing

NDC Package Code
69488-003-01
Package Description
1 VIAL in 1 PACKAGE / 20.5 mL in 1 VIAL
Product Code
69488-003
11-Digit Billing Format
69488000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lutathera
Non-Proprietary Name
Lutetium Lu 177 Dotatate
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
LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Regulatory & Marketing

Labeler Name
Advanced Accelerator Applications Usa, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208700
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-26-2018
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

A9513
Source: OPPS
Lutetium lu 177 dotatat ther
HCPCS Dosage 1 mCi
Units / Pkg 200

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 69488-003-01 identifies a specific commercial package of 1 vial in 1 package / 20.5 ml in 1 vial of Lutathera, a human prescription drug labeled by Advanced Accelerator Applications Usa, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Advanced Accelerator Applications Usa, Inc on January 26, 2018. The current certification is valid through December 31, 2027.

How is this Advanced Accelerator Applications Usa, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69488000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
69488-003-01
11-Digit CMS (5-4-2)
69488-0003-01

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