Akynzeo Capsule
NDC Package 69639-101-04

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

Akynzeo (netupitant and palonosetron) capsules is a medication a combination of 2 medications: fosnetupitant and palonosetron. This formulation utilizes a capsule delivery system. Marketed by Helsinn Therapeutics (u.s.), Inc., this product is identified by NDC 69639-101 and is authorized under FDA application NDA205718.

Identification & Billing

NDC Package Code
69639-101-04
Package Description
2 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
Product Code
69639-101
11-Digit Billing Format
69639010104
RxNorm Crosswalk
  • RxCUI: 1552343 - netupitant 300 MG / palonosetron 0.5 MG Oral Capsule
  • RxCUI: 1552343 - netupitant 300 MG / palonosetron 0.5 MG (as palonosetron hydrochloride 0.56 MG) Oral Capsule
  • RxCUI: 1552349 - Akynzeo 300 MG / 0.5 MG Oral Capsule
  • RxCUI: 1552349 - netupitant 300 MG / palonosetron 0.5 MG Oral Capsule [Akynzeo]
  • RxCUI: 1552349 - Akynzeo (netupitant 300 MG / palonosetron 0.5 MG (palonosetron hydrochloride 0.56 MG)) Oral Capsule

Clinical Specifications

Proprietary Name
Akynzeo
Non-Proprietary Name
Netupitant And Palonosetron
Substance Name
Netupitant; Palonosetron
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is a combination of 2 medications: fosnetupitant and palonosetron. It is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosnetupitant and palonosetron work by blocking natural substances in the body (such as substance P/neurokinin 1, serotonin) that cause vomiting.

Regulatory & Marketing

Labeler Name
Helsinn Therapeutics (u.s.), Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205718
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-13-2014
Listing Expiration
12-31-2027
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 (69639-101). Click a package code to view its specific billing and regulatory data.

69639-101-01
1 BLISTER PACK in 1 CARTON / 1 CAPSULE 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 69639-101-04 identifies a specific commercial package of 2 blister pack in 1 carton / 2 capsule in 1 blister pack of Akynzeo, a human prescription drug labeled by Helsinn Therapeutics (u.s.), Inc.. This capsule is formulated for oral use and contains netupitant; palonosetron 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 Helsinn Therapeutics (u.s.), Inc. on October 13, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This product is a combination of 2 medications: fosnetupitant and palonosetron. It is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosnetupitant and palonosetron work by blocking natural substances in the body (such as substance P/neurokinin 1, serotonin) that cause vomiting.

How is this Helsinn Therapeutics (u.s.), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69639010104. 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)
69639-101-04
11-Digit CMS (5-4-2)
69639-0101-04

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