NDC Package 65628-205-10 Firvanq

Vancomycin Hydrochloride Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

65628-205-10

Package Description:

1 KIT in 1 CARTON * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE

Product Code:

65628-205

Proprietary Name:

Firvanq

Non-Proprietary Name:

Vancomycin Hydrochloride

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.

11-Digit NDC Billing Format:

65628020510

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 2000127 - vancomycin 25 MG/mL Oral Solution

RxCUI: 2000127 - vancomycin 25 MG/ML Oral Solution

RxCUI: 2000127 - vancomycin (as vancomycin hydrochloride) 25 MG/ML Oral Solution

RxCUI: 2000127 - vancomycin 3.75 GM per 147 ML Powder for Oral Solution

RxCUI: 2000127 - vancomycin 7.5 GM per 295 ML Powder for Oral Solution

Product Type:

Human Prescription Drug

Labeler Name:

Azurity Pharmaceuticals, Inc

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

NDA208910

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

01-26-2018

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

65628 - Azurity Pharmaceuticals, Inc
- 65628-205 - Firvanq
  - 65628-205-10 - 1 KIT in 1 CARTON * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 65628-205-10?

The NDC Packaged Code 65628-205-10 is assigned to a package of 1 kit in 1 carton * 7.5 g in 1 bottle * 295 ml in 1 bottle of Firvanq, a human prescription drug labeled by Azurity Pharmaceuticals, Inc. The product's dosage form is kit and is administered via form.

Is NDC 65628-205 included in the NDC Directory?

Yes, Firvanq with product code 65628-205 is active and included in the NDC Directory. The product was first marketed by Azurity Pharmaceuticals, Inc on January 26, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 65628-205-10?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 65628-205-10?

The 11-digit format is 65628020510. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	65628-205-10	5-4-2	65628-0205-10

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