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  5. NDC Package Code: 55513-077-01 Imdelltra (amg757)

NDC Package 55513-077-01 Imdelltra (amg757)

Tarlatamab-dlle Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
55513-077-01
Package Description:
1 KIT in 1 PACKAGE * 10 mg in 1 VIAL (55513-069-01) * 7 mL in 1 VIAL (55513-068-01)
Product Code:
55513-077
Proprietary Name:
Imdelltra (amg757)
Non-Proprietary Name:
Tarlatamab-dlle
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).
11-Digit NDC Billing Format:
55513007701
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Amgen Inc
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
BLA761344
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
05-16-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 55513-077-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
55513007701J9026INJECTION, TARLATAMAB-DLLE, 1 MG1 MG1EA

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55513-077-01?

The NDC Packaged Code 55513-077-01 is assigned to a package of 1 kit in 1 package * 10 mg in 1 vial (55513-069-01) * 7 ml in 1 vial (55513-068-01) of Imdelltra (amg757), a human prescription drug labeled by Amgen Inc. The product's dosage form is kit and is administered via form.

Is NDC 55513-077 included in the NDC Directory?

Yes, Imdelltra (amg757) with product code 55513-077 is active and included in the NDC Directory. The product was first marketed by Amgen Inc on May 16, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 55513-077-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 55513-077-01?

The 11-digit format is 55513007701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-255513-077-015-4-255513-0077-01