Tukysa Tablet
NDC Package 51144-002-60

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

Package Information

Tukysa (tucatinib) tablets is tUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This formulation utilizes a tablet delivery system. Marketed by Seagen Inc., this product is identified by NDC 51144-002 and is authorized under FDA application NDA213411.

Identification & Billing

NDC Package Code
51144-002-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
51144-002
11-Digit Billing Format
51144000260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tukysa
Non-Proprietary Name
Tucatinib
Substance Name
Tucatinib
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TUCATINIB 150 mg/1
Pharmacologic Class
Usage Information
TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Regulatory & Marketing

Labeler Name
Seagen Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213411
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-17-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51144-002). Click a package code to view its specific billing and regulatory data.

51144-002-12
120 TABLET in 1 BOTTLE

* 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 51144-002-60 identifies a specific commercial package of 60 tablet in 1 bottle of Tukysa, a human prescription drug labeled by Seagen Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet is formulated for oral use and contains tucatinib 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 Seagen Inc. on April 17, 2020. The current certification is valid through December 31, 2026.

How is this Seagen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51144000260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
51144-002-60
11-Digit CMS (5-4-2)
51144-0002-60

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