Akynzeo Injection
NDC Package 69639-105-01

11-digit billing NDC: 69639010501 · Billing unit: ML · 20 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Akynzeo (fosnetupitant and palonosetron) injection is aKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. This formulation utilizes a injection delivery system. Marketed by Helsinn Therapeutics (u.s.), Inc., this product is identified by NDC 69639-105 and is authorized under FDA application NDA210493.

Identification & Billing

NDC Package Code
69639-105-01
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
69639-105
11-Digit Billing Format
69639010501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML
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
Fosnetupitant And Palonosetron
Substance Name
Fosnetupitant; Palonosetron Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

Regulatory & Marketing

Labeler Name
Helsinn Therapeutics (u.s.), Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210493
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-15-2020
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1454
Source: ASP
Inj fosnetupitant, palonoset
HCPCS Dosage 0.25 MG
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 69639-105-01 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial of Akynzeo, a human prescription drug labeled by Helsinn Therapeutics (u.s.), Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package. This injection is formulated for intravenous use and contains fosnetupitant; palonosetron 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 Helsinn Therapeutics (u.s.), Inc. on June 15, 2020. The current certification is valid through December 31, 2027.

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: 69639010501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 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)
69639-105-01
11-Digit CMS (5-4-2)
69639-0105-01

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