Vancomycin Hydrochloride For Oral Solution Kit
NDC Package 52536-104-05

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

Package Information

Vancomycin Hydrochloride For Oral Solution (vancomycin hydrochloride) kits is vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age.Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.Important Limitations of Use•Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.•Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.To reduce the development of drug‑resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a kit delivery system. Marketed by Wilshire Pharmaceuticals, Inc., this product is identified by NDC 52536-104 and is authorized under FDA application NDA208910.

Identification & Billing

NDC Package Code
52536-104-05
Package Description
1 KIT in 1 CARTON * 3.75 g in 1 BOTTLE (52536-094-05) * 147 mL in 1 BOTTLE (52536-084-05)
Product Code
52536-104
11-Digit Billing Format
52536010405
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 Hydrochloride For Oral Solution
Non-Proprietary Name
Vancomycin Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age.Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.Important Limitations of Use•Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.•Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.To reduce the development of drug‑resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Wilshire Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208910
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-31-2023
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 52536-104-05 identifies a specific commercial package of 1 kit in 1 carton * 3.75 g in 1 bottle (52536-094-05) * 147 ml in 1 bottle (52536-084-05) of Vancomycin Hydrochloride For Oral Solution, a human prescription drug labeled by Wilshire 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 Wilshire Pharmaceuticals, Inc. on March 31, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52536010405. 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)
52536-104-05
11-Digit CMS (5-4-2)
52536-0104-05

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