Akynzeo Injection
NDC Package 69639-102-01

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

Package Information

Akynzeo (fosnetupitant and palonosetron) injection is a medication a combination of 2 medications: fosnetupitant and palonosetron. This formulation utilizes a injection delivery system. Marketed by Helsinn Therapeutics (u.s.), Inc., this product is identified by NDC 69639-102 and is authorized under FDA application NDA210493.

Identification & Billing

NDC Package Code
69639-102-01
Package Description
1 VIAL in 1 CARTON / 1 INJECTION in 1 VIAL
Product Code
69639-102
11-Digit Billing Format
69639010201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
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 #
NDA210493
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-20-2018
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: PDAC
INJECTION, FOSNETUPITANT 235 MG AND PALONOSETRON 0.25 MG
HCPCS Dosage 235.25 MG
Units / Pkg

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 69639-102-01 identifies a specific commercial package of 1 vial in 1 carton / 1 injection in 1 vial of Akynzeo, a human prescription drug labeled by Helsinn Therapeutics (u.s.), Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 April 20, 2018. 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: 69639010201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
69639-102-01
11-Digit CMS (5-4-2)
69639-0102-01

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