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  5. NDC Package Code: 63629-1970-1 Vancomycin Hydrochloride

NDC Package 63629-1970-1 Vancomycin Hydrochloride

Powder, For Solution Oral - 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:
63629-1970-1
Package Description:
80 mL in 1 BOTTLE
Product Code:
63629-1970
Proprietary Name:
Vancomycin Hydrochloride
Non-Proprietary Name:
Vancomycin Hydrochloride
Substance Name:
Vancomycin Hydrochloride
Usage Information:
Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution 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:
63629197001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
80 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 2000134 - vancomycin 50 MG/mL Oral Solution
  • RxCUI: 2000134 - vancomycin 50 MG/ML Oral Solution
  • RxCUI: 2000134 - vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution
  • RxCUI: 2000134 - vancomycin 15 GM per 289 ML Powder for Oral Solution
  • RxCUI: 2000134 - vancomycin 250 MG per 5 ML Powder for Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • VANCOMYCIN HYDROCHLORIDE 250 mg/5mL
    • Pharmacologic Class(es):
  • Glycopeptide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Glycopeptides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA061667
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-09-2019
    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 63629-1970-1?

    The NDC Packaged Code 63629-1970-1 is assigned to a package of 80 ml in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is powder, for solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 80 billable units per package.

    Is NDC 63629-1970 included in the NDC Directory?

    Yes, Vancomycin Hydrochloride with product code 63629-1970 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on September 09, 2019 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 63629-1970-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 80.

    What is the 11-digit format for NDC 63629-1970-1?

    The 11-digit format is 63629197001. 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 5-4-1 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
    5-4-163629-1970-15-4-263629-1970-01