Levofloxacin Tablet, Film Coated
NDC Package 51655-666-07

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

Levofloxacin tablets is levofloxacin is used to treat a variety of bacterial infections. This formulation utilizes a tablet, film coated delivery system. Marketed by Northwind Health Company, Llc, this product is identified by NDC 51655-666 and is authorized under FDA application ANDA076710.

Identification & Billing

NDC Package Code
51655-666-07
Package Description
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
51655-666
11-Digit Billing Format
51655066607
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levofloxacin
Non-Proprietary Name
Levofloxacin
Substance Name
Levofloxacin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOFLOXACIN 500 mg/1
Usage Information
Levofloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. 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.

Regulatory & Marketing

Labeler Name
Northwind Health Company, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076710
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51655-666). Click a package code to view its specific billing and regulatory data.

51655-666-53
10 TABLET, FILM COATED in 1 BOTTLE
51655-666-84
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 51655-666-07 identifies a specific commercial package of 7 tablet, film coated in 1 bottle, plastic of Levofloxacin, a human prescription drug labeled by Northwind Health Company, Llc. This tablet, film coated is formulated for oral use and contains levofloxacin 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 Northwind Health Company, Llc on January 08, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Levofloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. 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.

How is this Northwind Health Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51655066607. 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)
51655-666-07
11-Digit CMS (5-4-2)
51655-0666-07

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