Tepmetko Tablet
NDC Package 44087-5000-3

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

Tepmetko (tepotinib hydrochloride) tablets is tEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. This formulation utilizes a tablet delivery system. Marketed by Emd Serono, Inc., this product is identified by NDC 44087-5000 and is authorized under FDA application NDA214096.

Identification & Billing

NDC Package Code
44087-5000-3
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
44087-5000
11-Digit Billing Format
44087500003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tepmetko
Non-Proprietary Name
Tepotinib Hydrochloride
Substance Name
Tepotinib Hydrochloride
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)
TEPOTINIB HYDROCHLORIDE 225 mg/1
Pharmacologic Class
Usage Information
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.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 confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Emd Serono, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214096
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-03-2021
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 (44087-5000). Click a package code to view its specific billing and regulatory data.

44087-5000-6
6 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

* 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 44087-5000-3 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet in 1 blister pack of Tepmetko, a human prescription drug labeled by Emd Serono, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This tablet is formulated for oral use and contains tepotinib hydrochloride 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 Emd Serono, Inc. on February 03, 2021. The current certification is valid through December 31, 2026.

How is this Emd Serono, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44087500003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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 (5-4-1)
44087-5000-3
11-Digit CMS (5-4-2)
44087-5000-03

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