Nitrofurantoin Suspension
NDC Package 43386-450-11

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

Package Information

Nitrofurantoin suspension is nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. This formulation utilizes a suspension delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-450 and is authorized under FDA application ANDA201693.

Identification & Billing

NDC Package Code
43386-450-11
Package Description
1 BOTTLE in 1 CARTON / 230 mL in 1 BOTTLE
Product Code
43386-450
11-Digit Billing Format
43386045011
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitrofurantoin
Non-Proprietary Name
Nitrofurantoin
Substance Name
Nitrofurantoin
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 25 mg/5mL
Pharmacologic Class
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
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA201693
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-21-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43386-450-11 identifies a specific commercial package of 1 bottle in 1 carton / 230 ml in 1 bottle of Nitrofurantoin, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This suspension is formulated for oral use and contains nitrofurantoin 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 Lupin Pharmaceuticals,inc. on May 21, 2015. The current certification is valid through December 31, 2026.

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 Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386045011. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
43386-450-11
11-Digit CMS (5-4-2)
43386-0450-11

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