Nitrofurantoin Macrocrystals Capsule
NDC Package 43386-641-01

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

Package Information

Nitrofurantoin Macrocrystals capsules is nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. This formulation utilizes a capsule delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-641 and is authorized under FDA application ANDA203233.

Identification & Billing

NDC Package Code
43386-641-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
43386-641
11-Digit Billing Format
43386064101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitrofurantoin Macrocrystals
Non-Proprietary Name
Nitrofurantoin Macrocrystals
Substance Name
Nitrofurantoin
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)
NITROFURANTOIN 50 mg/1
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 #
ANDA203233
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-09-2018
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 43386-641-01 identifies a specific commercial package of 100 capsule in 1 bottle of Nitrofurantoin Macrocrystals, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This capsule 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 July 09, 2018. 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: 43386064101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:

10-Digit Format (5-3-2)
43386-641-01
11-Digit CMS (5-4-2)
43386-0641-01

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