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  5. NDC Package Code: 52536-104-05 Vancomycin Hydrochloride For Oral Solution

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

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

Table of Contents

    1. Package Information
    2. 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:
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
Proprietary Name:
Vancomycin Hydrochloride For Oral Solution
Non-Proprietary Name:
Vancomycin Hydrochloride
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.
11-Digit NDC Billing Format:
52536010405
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:
    Wilshire Pharmaceuticals, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 52536-104-05?

    The NDC Packaged Code 52536-104-05 is assigned to a 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.. The product's dosage form is kit and is administered via form.

    Is NDC 52536-104 included in the NDC Directory?

    Yes, Vancomycin Hydrochloride For Oral Solution with product code 52536-104 is active and included in the NDC Directory. The product was first marketed by Wilshire Pharmaceuticals, Inc. on March 31, 2023 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 52536-104-05?

    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 52536-104-05?

    The 11-digit format is 52536010405. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252536-104-055-4-252536-0104-05