Macrodantin Capsule
NDC Package 52427-286-01

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

Package Information

Macrodantin (nitrofurantoin macrocrystals) capsules is a medication used to treat or prevent certain urinary tract infections. This formulation utilizes a capsule delivery system. Marketed by Almatica Pharma Llc, this product is identified by NDC 52427-286 and is authorized under FDA application NDA016620.

Identification & Billing

NDC Package Code
52427-286-01
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
52427-286
11-Digit Billing Format
52427028601
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
Macrodantin
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 25 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat or prevent certain urinary tract infections. This medication is an antibiotic that works by stopping the growth of bacteria. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness. Nitrofurantoin should not be used in children less than one month of age due to the risk of a certain blood problem (hemolytic anemia).

Regulatory & Marketing

Labeler Name
Almatica Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
NDA016620
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-2010
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 52427-286-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Macrodantin, a human prescription drug labeled by Almatica Pharma Llc. 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 Almatica Pharma Llc on September 27, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat or prevent certain urinary tract infections. This medication is an antibiotic that works by stopping the growth of bacteria. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness. Nitrofurantoin should not be used in children less than one month of age due to the risk of a certain blood problem (hemolytic anemia).

How is this Almatica Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52427028601. 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)
52427-286-01
11-Digit CMS (5-4-2)
52427-0286-01

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