Firvanq Kit
NDC Package 65628-206-05

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

Package Information

Firvanq (vancomycin hydrochloride) kits is vancomycin is an antibiotic used to treat infections. This formulation utilizes a kit delivery system. Marketed by Azurity Pharmaceuticals, Inc, this product is identified by NDC 65628-206 and is authorized under FDA application NDA208910.

Identification & Billing

NDC Package Code
65628-206-05
Package Description
1 KIT in 1 CARTON * 7.5 g in 1 BOTTLE * 145 mL in 1 BOTTLE
Product Code
65628-206
11-Digit Billing Format
65628020605
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Firvanq
Non-Proprietary Name
Vancomycin Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Vancomycin is an antibiotic used to treat infections. This form of vancomycin is used to treat a certain intestinal condition (colitis) caused by bacteria. This condition causes diarrhea and stomach/abdominal discomfort or pain. When vancomycin is taken by mouth, it stays in the intestines to stop the growth of certain bacteria that cause these symptoms. This antibiotic treats only bacterial infection in the intestines. It will not work for bacterial infections in any other part of the body or for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Azurity Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208910
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-26-2018
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 65628-206-05 identifies a specific commercial package of 1 kit in 1 carton * 7.5 g in 1 bottle * 145 ml in 1 bottle of Firvanq, a human prescription drug labeled by Azurity Pharmaceuticals, Inc. This kit is formulated for use and contains 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 Azurity Pharmaceuticals, Inc on January 26, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Vancomycin is an antibiotic used to treat infections. This form of vancomycin is used to treat a certain intestinal condition (colitis) caused by bacteria. This condition causes diarrhea and stomach/abdominal discomfort or pain. When vancomycin is taken by mouth, it stays in the intestines to stop the growth of certain bacteria that cause these symptoms. This antibiotic treats only bacterial infection in the intestines. It will not work for bacterial infections in any other part of the body or for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Azurity Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65628020605. 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)
65628-206-05
11-Digit CMS (5-4-2)
65628-0206-05

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