Focinvez Injection
NDC Package 82449-231-01

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

Package Information

Focinvez (fosaprepitant dimeglumine) injection is fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). This formulation utilizes a injection delivery system. Marketed by Steriscience Specialties Private Limited, this product is identified by NDC 82449-231 and is authorized under FDA application NDA216686.

Identification & Billing

NDC Package Code
82449-231-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code
82449-231
11-Digit Billing Format
82449023101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Focinvez
Non-Proprietary Name
Fosaprepitant Dimeglumine
Substance Name
Fosaprepitant Dimeglumine
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)
FOSAPREPITANT DIMEGLUMINE 150 mg/50mL
Pharmacologic Class
Usage Information
Fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosaprepitant works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting. This medication will not treat nausea or vomiting that has already started. Ask your doctor what you should do if you already have nausea or vomiting.

Regulatory & Marketing

Labeler Name
Steriscience Specialties Private Limited
Product Type
Human Prescription Drug
FDA Application #
NDA216686
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82449-231-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Focinvez, a human prescription drug labeled by Steriscience Specialties Private Limited. This injection is formulated for intravenous use and contains fosaprepitant dimeglumine 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 Steriscience Specialties Private Limited on June 26, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Fosaprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). Fosaprepitant works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting. This medication will not treat nausea or vomiting that has already started. Ask your doctor what you should do if you already have nausea or vomiting.

How is this Steriscience Specialties Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82449023101. 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)
82449-231-01
11-Digit CMS (5-4-2)
82449-0231-01

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