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  5. NDC Package Code: 61919-024-28 Nitrofurantion

NDC Package 61919-024-28 Nitrofurantion

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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:
61919-024-28
Package Description:
28 CAPSULE in 1 BOTTLE
Product Code:
61919-024
Proprietary Name:
Nitrofurantion
Usage Information:
Nitrofurantoin Capsules, USP (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 Capsules, USP (macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (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 Capsules, USP (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 Capsules, USP (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (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:
61919002428
NDC to RxNorm Crosswalk:
  • RxCUI: 311995 - nitrofurantoin macrocrystals 50 MG Oral Capsule
  • RxCUI: 311995 - nitrofurantoin, macrocrystals 50 MG Oral Capsule
    • Labeler Name:
    Direct Rx
    Sample Package:
    No
    Start Marketing Date:
    04-15-2016
    Listing Expiration Date:
    12-31-2022
    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 61919-024-28?

    The NDC Packaged Code 61919-024-28 is assigned to a package of 28 capsule in 1 bottle of Nitrofurantion, labeled by Direct Rx. The product's dosage form is and is administered via form.

    Is NDC 61919-024 included in the NDC Directory?

    No, Nitrofurantion with product code 61919-024 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Direct Rx on April 15, 2016 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61919-024-28?

    The 11-digit format is 61919002428. 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
    5-3-261919-024-285-4-261919-0024-28