Palonosetron Injection
NDC Package 67184-0515-2

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

Package Information

Palonosetron (palonosetron hydrochloride) injection is palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components  [see Adverse Reactions (6.2)]. This formulation utilizes a injection delivery system. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-0515 and is authorized under FDA application ANDA205648.

Identification & Billing

NDC Package Code
67184-0515-2
Package Description
5 VIAL in 1 CARTON / 1.5 mL in 1 VIAL (67184-0515-1)
Product Code
67184-0515
11-Digit Billing Format
67184051502
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Palonosetron
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 .075 mg/1.5mL
Pharmacologic Class
Usage Information
Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components  [see Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Qilu Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA205648
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-19-2018
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 67184-0515-2 identifies a specific commercial package of 5 vial in 1 carton / 1.5 ml in 1 vial (67184-0515-1) of Palonosetron, a human prescription drug labeled by Qilu Pharmaceutical Co., Ltd.. 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 Qilu Pharmaceutical Co., Ltd. on September 19, 2018. The current certification is valid through December 31, 2026.

How is this Qilu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67184051502. 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 (5-4-1)
67184-0515-2
11-Digit CMS (5-4-2)
67184-0515-02

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