Palonosetron Hydrochloride Injection
NDC Package 36000-326-02

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

Palonosetron Hydrochloride injection is indicated in adults for prevention of:•acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).•acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).•postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. This formulation utilizes a injection delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 36000-326 and is authorized under FDA application ANDA206916.

Identification & Billing

NDC Package Code
36000-326-02
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL (36000-326-01)
Product Code
36000-326
11-Digit Billing Format
36000032602
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Palonosetron Hydrochloride
Non-Proprietary Name
Palonosetron Hydrochloride
Substance Name
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)
PALONOSETRON HYDROCHLORIDE .25 mg/5mL
Pharmacologic Class
Usage Information
Palonosetron hydrochloride injection is indicated in adults for prevention of:•acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).•acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).•postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA206916
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-12-2021
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.

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.

J2469
Source: ASP
Palonosetron hcl
HCPCS Dosage 25 MCG
Units / Pkg 10

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 36000-326-02 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial (36000-326-01) of Palonosetron Hydrochloride, a human prescription drug labeled by Baxter Healthcare Corporation. This injection is formulated for intravenous use and contains 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 Baxter Healthcare Corporation on November 12, 2021. The current certification is valid through December 31, 2026.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36000032602. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
36000-326-02
11-Digit CMS (5-4-2)
36000-0326-02

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