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  5. NDC Package Code: 10544-601-20 Nitrofurantoin Macrocrystals

NDC Package 10544-601-20 Nitrofurantoin Macrocrystals

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:
10544-601-20
Package Description:
20 CAPSULE in 1 BOTTLE
Product Code:
10544-601
Proprietary Name:
Nitrofurantoin Macrocrystals
Usage Information:
Nitrofurantoin macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals and other antibacterial drugs, nitrofurantoin macrocrystals 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.Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
11-Digit NDC Billing Format:
10544060120
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1648759 - nitrofurantoin macrocrystals 100 MG Oral Capsule
  • RxCUI: 1648759 - nitrofurantoin, macrocrystals 100 MG Oral Capsule
    • Labeler Name:
    Blenheim Pharmacal, Inc.
    Sample Package:
    No
    Start Marketing Date:
    04-23-2010
    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 10544-601-20?

    The NDC Packaged Code 10544-601-20 is assigned to a package of 20 capsule in 1 bottle of Nitrofurantoin Macrocrystals, labeled by Blenheim Pharmacal, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package.

    Is NDC 10544-601 included in the NDC Directory?

    No, Nitrofurantoin Macrocrystals with product code 10544-601 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Blenheim Pharmacal, Inc. on April 23, 2010 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 NDC billing unit for package 10544-601-20?

    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 20.

    What is the 11-digit format for NDC 10544-601-20?

    The 11-digit format is 10544060120. 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
    5-3-210544-601-205-4-210544-0601-20