Vancomycin Hydrochloride Injection, Powder, Lyophilized, For Solution
NDC Package 68083-596-10

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

Package Information

Vancomycin Hydrochloride injection is vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to vancomycin. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-596 and is authorized under FDA application ANDA218140.

Identification & Billing

NDC Package Code
68083-596-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-596-01)
Product Code
68083-596
11-Digit Billing Format
68083059610
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vancomycin Hydrochloride
Non-Proprietary Name
Vancomycin Hydrochloride
Substance Name
Vancomycin Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
VANCOMYCIN HYDROCHLORIDE 1.25 g/1
Pharmacologic Class
Usage Information
Vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to vancomycin.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218140
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-21-2025
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 68083-596-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (68083-596-01) of Vancomycin Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains vancomycin hydrochloride 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 Gland Pharma Limited on March 21, 2025. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083059610. 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)
68083-596-10
11-Digit CMS (5-4-2)
68083-0596-10

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