NDC Package 63323-295-61 Vancomycin Hydrochloride

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
63323-295-61
Package Description:
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Vancomycin Hydrochloride
Non-Proprietary Name:
Vancomycin Hydrochloride
Substance Name:
Vancomycin Hydrochloride
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP 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.Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-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 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 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 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 vancomycin 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.
11-Digit NDC Billing Format:
63323029561
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 239209 - vancomycin 100 MG/ML Injectable Solution
  • RxCUI: 239209 - vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable Solution
  • RxCUI: 313572 - vancomycin 50 MG/ML Injectable Solution
  • RxCUI: 313572 - vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    ANDA062663
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-17-2001
    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.

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    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 63323-295-61 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63323029561J3370Vancomycin hcl injection500 MG111010

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    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63323-295-661 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

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    Frequently Asked Questions

    What is NDC 63323-295-61?

    The NDC Packaged Code 63323-295-61 is assigned to a package of 1 bottle in 1 carton / 100 ml in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 63323-295 included in the NDC Directory?

    Yes, Vancomycin Hydrochloride with product code 63323-295 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on July 17, 2001 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 63323-295-61?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 63323-295-61?

    The 11-digit format is 63323029561. 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
    5-3-263323-295-615-4-263323-0295-61