Nitrofurantoin
NDC Package 70408-239-32
Package Information
Nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. Marketed by Nostrum Laboratories, Inc., this product is identified by NDC 70408-239 and is authorized under FDA application ANDA201355.
Identification & Billing
- RxCUI: 311989 - nitrofurantoin 25 MG in 5 mL Oral Suspension
- RxCUI: 311989 - nitrofurantoin 5 MG/ML Oral Suspension
- RxCUI: 311989 - nitrofurantoin 25 MG per 5 ML Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 70408 - Nostrum Laboratories, Inc.
- 70408-239 - Nitrofurantoin
- 70408-239-32 - 240 mL in 1 BOTTLE, PLASTIC
- 70408-239 - Nitrofurantoin
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 70408-239-32 identifies a specific commercial package of 240 ml in 1 bottle, plastic of Nitrofurantoin, labeled by Nostrum Laboratories, 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 Nostrum Laboratories, Inc. on March 04, 2012. The current certification is valid through December 31, 2025.
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 Nostrum Laboratories, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 70408023932. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.