Focinvez
NDC Package 82243-1001-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Focinvez is in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).Limitations of Use FOCINVEZ has not been studied for treatment of established nausea and vomiting. Marketed by Spes Pharmaceuticals Inc., this product is identified by NDC 82243-1001 and is authorized under FDA application NDA216686.

Identification & Billing

NDC Package Code
82243-1001-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code
82243-1001
11-Digit Billing Format
82243100101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Focinvez
Dosage Form
-
Usage Information
FOCINVEZ, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).Limitations of Use FOCINVEZ has not been studied for treatment of established nausea and vomiting.

Regulatory & Marketing

Labeler Name
Spes Pharmaceuticals Inc.
FDA Application #
NDA216686
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-30-2023
Listing Expiration
12-31-2024
Exclude Flag
I
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 82243-1001-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Focinvez, labeled by Spes Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Spes Pharmaceuticals Inc. on August 30, 2023. The current certification is valid through December 31, 2024.

How is this Spes Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82243100101. 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)
82243-1001-1
11-Digit CMS (5-4-2)
82243-1001-01

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