Nitrofurantoin Suspension
NDC Package 64980-593-24

11-digit billing NDC: 64980059324
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nitrofurantoin suspension is nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species.Limitations of UseNitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)].UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a suspension delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 64980-593 and is authorized under FDA application ANDA212607.

Identification & Billing

NDC Package Code
64980-593-24
Package Description
1 BOTTLE in 1 CARTON / 230 mL in 1 BOTTLE
Product Code
64980-593
11-Digit Billing Format
64980059324
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitrofurantoin
Non-Proprietary Name
Nitrofurantoin
Substance Name
Nitrofurantoin Monohydrate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NITROFURANTOIN MONOHYDRATE 25 mg/5mL
Pharmacologic Class
Usage Information
Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species.Limitations of UseNitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)].UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension 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.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212607
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-11-2023
Listing Expiration
12-31-2027
Exclude Flag
N
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 64980-593-24 identifies a specific commercial package of 1 bottle in 1 carton / 230 ml in 1 bottle of Nitrofurantoin, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This suspension is formulated for oral use and contains nitrofurantoin monohydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rising Pharma Holdings, Inc. on May 11, 2023. The current certification is valid through December 31, 2027.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980059324. 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)
64980-593-24
11-Digit CMS (5-4-2)
64980-0593-24

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