Palonosetron Injection, Solution
NDC Package 55111-694-19

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

Palonosetron injection is palonosetron hydrochloride injection is indicated for:• Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses• Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses. This formulation utilizes a injection, solution delivery system. Marketed by Dr.reddy's Laboratories Limited, this product is identified by NDC 55111-694 and is authorized under FDA application ANDA201533.

Identification & Billing

NDC Package Code
55111-694-19
Package Description
5 VIAL, SINGLE-USE in 1 CARTON / 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15)
Product Code
55111-694
11-Digit Billing Format
55111069419
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Palonosetron
Non-Proprietary Name
Palonosetron
Substance Name
Palonosetron Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PALONOSETRON HYDROCHLORIDE .05 mg/mL
Pharmacologic Class
Usage Information
Palonosetron hydrochloride injection is indicated for:• Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses• Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses

Regulatory & Marketing

Labeler Name
Dr.reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA201533
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-694). Click a package code to view its specific billing and regulatory data.

55111-694-07
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE

* 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 55111-694-19 identifies a specific commercial package of 5 vial, single-use in 1 carton / 1.5 ml in 1 vial, single-use (55111-694-15) of Palonosetron, a human prescription drug labeled by Dr.reddy's Laboratories Limited. This injection, solution 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 Dr.reddy's Laboratories Limited on March 23, 2018. The current certification is valid through December 31, 2026.

How is this Dr.reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111069419. 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)
55111-694-19
11-Digit CMS (5-4-2)
55111-0694-19

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