Vancomycin Injection, Solution
NDC Package 70594-044-02

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

Package Information

Vancomycin injection is vancomycin is used to treat serious bacterial infections. This formulation utilizes a injection, solution delivery system. Marketed by Xellia Pharmaceuticals Usa Llc, this product is identified by NDC 70594-044 and is authorized under FDA application NDA211962.

Identification & Billing

NDC Package Code
70594-044-02
Package Description
6 BAG in 1 CARTON / 400 mL in 1 BAG (70594-044-01)
Product Code
70594-044
11-Digit Billing Format
70594004402
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vancomycin
Non-Proprietary Name
Vancomycin
Substance Name
Vancomycin
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)
VANCOMYCIN 2 g/400mL
Pharmacologic Class
Usage Information
Vancomycin is used to treat serious bacterial infections. It is an antibiotic that works by stopping the growth of bacteria. This medication is usually given by injection into a vein. However, the form in vials may also be given by mouth to treat a certain intestinal condition (colitis) that may rarely happen after treatment with antibiotics. 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 bacteria that cause these symptoms. This antibiotic treats only bacterial infections. It will not work 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
Xellia Pharmaceuticals Usa Llc
Product Type
Human Prescription Drug
FDA Application #
NDA211962
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-15-2019
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 70594-044-02 identifies a specific commercial package of 6 bag in 1 carton / 400 ml in 1 bag (70594-044-01) of Vancomycin, a human prescription drug labeled by Xellia Pharmaceuticals Usa Llc. This injection, solution is formulated for intravenous use and contains vancomycin 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 Xellia Pharmaceuticals Usa Llc on February 15, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Vancomycin is used to treat serious bacterial infections. It is an antibiotic that works by stopping the growth of bacteria. This medication is usually given by injection into a vein. However, the form in vials may also be given by mouth to treat a certain intestinal condition (colitis) that may rarely happen after treatment with antibiotics. 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 bacteria that cause these symptoms. This antibiotic treats only bacterial infections. It will not work 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 Xellia Pharmaceuticals Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70594004402. 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)
70594-044-02
11-Digit CMS (5-4-2)
70594-0044-02

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