Nitrofurantoin Mono Capsule
NDC Package 54348-849-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Nitrofurantoin Mono (nitrofurantoin monohydrate) capsules is nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. This formulation utilizes a capsule delivery system. Marketed by Pharmpak, Inc., this product is identified by NDC 54348-849 and is authorized under FDA application NDA020064.

Identification & Billing

NDC Package Code
54348-849-10
Package Description
1 BOTTLE in 1 BOX / 10 CAPSULE in 1 BOTTLE
Product Code
54348-849
11-Digit Billing Format
54348084910
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 Mono
Non-Proprietary Name
Nitrofurantoin Monohydrate
Substance Name
Nitrofurantoin; Nitrofurantoin Monohydrate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Nitrofurantoin monohydrate/macrocrystals capsules 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 monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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 monohydrate/macrocrystals capsules 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 monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, 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
Pharmpak, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020064
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-10-2019
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54348-849). Click a package code to view its specific billing and regulatory data.

54348-849-06
1 BOTTLE in 1 BOX / 6 CAPSULE in 1 BOTTLE
54348-849-14
1 BOTTLE in 1 BOX / 14 CAPSULE in 1 BOTTLE

* 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 54348-849-10 identifies a specific commercial package of 1 bottle in 1 box / 10 capsule in 1 bottle of Nitrofurantoin Mono, a human prescription drug labeled by Pharmpak, Inc.. This capsule is formulated for oral use and contains nitrofurantoin; 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 Pharmpak, Inc. on July 10, 2019. The current certification is valid through December 31, 2026.

How is this Pharmpak, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54348084910. 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)
54348-849-10
11-Digit CMS (5-4-2)
54348-0849-10

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