Imdelltra (amg757) Kit
NDC Package 55513-059-01

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

Imdelltra (amg757) (tarlatamab-dlle) kits is iMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-059 and is authorized under FDA application BLA761344.

Identification & Billing

NDC Package Code
55513-059-01
Package Description
1 KIT in 1 PACKAGE * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01)
Product Code
55513-059
11-Digit Billing Format
55513005901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imdelltra (amg757)
Non-Proprietary Name
Tarlatamab-dlle
Dosage Form
Kit - A packaged collection of related material.
Usage Information
IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761344
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-16-2024
Listing Expiration
12-31-2026
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.

J9026
Source: ASP
Inj, tarlatamab-dlle, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 1

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 55513-059-01 identifies a specific commercial package of 1 kit in 1 package * 1 mg in 1 vial (55513-103-01) * 7 ml in 1 vial (55513-068-01) of Imdelltra (amg757), a human prescription drug labeled by Amgen, Inc. This kit is formulated for use and contains 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 Amgen, Inc on May 16, 2024. The current certification is valid through December 31, 2026.

How is this Amgen, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513005901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
55513-059-01
11-Digit CMS (5-4-2)
55513-0059-01

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