Nitrofurantoin Monohydrate/macrocrystals
NDC Package 76413-115-14

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Nitrofurantoin Monohydrate/macrocrystals is nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.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 (monohydrate/macrocrystals)and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals)should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-115 and is authorized under FDA application ANDA076648.

Identification & Billing

NDC Package Code
76413-115-14
Package Description
14 CAPSULE in 1 BOTTLE
Product Code
76413-115
11-Digit Billing Format
76413011514
RxNorm Crosswalk
  • RxCUI: 1648755 - nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule
  • RxCUI: 1648755 - nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule

Clinical Specifications

Proprietary Name
Nitrofurantoin Monohydrate/macrocrystals
Dosage Form
-
Usage Information
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.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 (monohydrate/macrocrystals)and other antibacterial drugs, nitrofurantoin capsules (monohydrate/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 (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) 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 (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/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.

Regulatory & Marketing

Labeler Name
Central Texas Community Health Centers
FDA Application #
ANDA076648
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-2004
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76413-115-14 identifies a specific commercial package of 14 capsule in 1 bottle of Nitrofurantoin Monohydrate/macrocrystals, labeled by Central Texas Community Health Centers. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Central Texas Community Health Centers on March 23, 2004. The current certification is valid through December 31, 2019.

How is this Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413011514. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76413-115-14
11-Digit CMS (5-4-2)
76413-0115-14

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.