Avmapki Fakzynja Co-pack Kit
NDC Package 71779-623-01

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

Package Information

Avmapki Fakzynja Co-pack (avutometinib potassium and defactinib hydrochloride) kits is aVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Verastem Inc., this product is identified by NDC 71779-623 and is authorized under FDA application NDA219616.

Identification & Billing

NDC Package Code
71779-623-01
Package Description
1 KIT in 1 CARTON * 24 CAPSULE in 1 BOTTLE (71779-660-02) * 42 TABLET in 1 BOTTLE (71779-630-01)
Product Code
71779-623
11-Digit Billing Format
71779062301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Avmapki Fakzynja Co-pack
Non-Proprietary Name
Avutometinib Potassium And Defactinib Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.This indication is approved under accelerated approval based on tumor 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.

Regulatory & Marketing

Labeler Name
Verastem Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219616
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-08-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71779-623-01 identifies a specific commercial package of 1 kit in 1 carton * 24 capsule in 1 bottle (71779-660-02) * 42 tablet in 1 bottle (71779-630-01) of Avmapki Fakzynja Co-pack, a human prescription drug labeled by Verastem 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 Verastem Inc. on May 08, 2025. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71779062301. 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)
71779-623-01
11-Digit CMS (5-4-2)
71779-0623-01

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