Nitrofurantoin
NDC Package 53002-7044-2

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-7044 and is authorized under FDA application ANDA217357.

Identification & Billing

NDC Package Code
53002-7044-2
Package Description
10 CAPSULE in 1 BOTTLE
Product Code
53002-7044
11-Digit Billing Format
53002704402

Clinical Specifications

Proprietary Name
Nitrofurantoin
Dosage Form
-
Usage Information
Nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA217357
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-14-2023
End Marketing Date
12-31-2024
Listing Expiration
12-31-2024
Exclude Flag
D
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 (53002-7044). Click a package code to view its specific billing and regulatory data.

53002-7044-1
6 CAPSULE in 1 BOTTLE
53002-7044-3
14 CAPSULE in 1 BOTTLE
53002-7044-4
20 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 53002-7044-2 identifies a specific commercial package of 10 capsule in 1 bottle of Nitrofurantoin, labeled by Rpk Pharmaceuticals, Inc.. 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 Rpk Pharmaceuticals, Inc. on September 14, 2023. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

Nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002704402. 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 (5-4-1)
53002-7044-2
11-Digit CMS (5-4-2)
53002-7044-02

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