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  5. NDC Package Code: 21695-424-01 Sterile Vancomycin Hydrochloride

NDC Package 21695-424-01 Sterile Vancomycin Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
21695-424-01
Package Description:
10 mL in 1 VIAL
Product Code:
21695-424
Proprietary Name:
Sterile Vancomycin Hydrochloride
Usage Information:
Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.Vancomycin hydrochloride has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.The parenteral form of Sterile Vancomycin Hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin 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:
21695042401
NDC to RxNorm Crosswalk:
  • RxCUI: 1807516 - vancomycin 500 MG Injection
  • RxCUI: 1807516 - vancomycin (as vancomycin HCl) 500 MG Injection
    • Labeler Name:
    Rebel Distributors Corp
    Sample Package:
    No
    Start Marketing Date:
    12-31-2008
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 21695-424-01?

    The NDC Packaged Code 21695-424-01 is assigned to a package of 10 ml in 1 vial of Sterile Vancomycin Hydrochloride, labeled by Rebel Distributors Corp. The product's dosage form is and is administered via form.

    Is NDC 21695-424 included in the NDC Directory?

    No, Sterile Vancomycin Hydrochloride with product code 21695-424 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rebel Distributors Corp on December 31, 2008 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 21695-424-01?

    The 11-digit format is 21695042401. 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
    5-3-221695-424-015-4-221695-0424-01