Moxifloxacin Solution/ Drops
NDC Package 80425-0239-1

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

Package Information

Moxifloxacin solution/ dropses is a medication a quinolone antibiotic used for eye infections. This formulation utilizes a solution/ drops delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0239 and is authorized under FDA application ANDA090080.

Identification & Billing

NDC Package Code
80425-0239-1
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER
Product Code
80425-0239
11-Digit Billing Format
80425023901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Moxifloxacin
Non-Proprietary Name
Moxifloxacin
Substance Name
Moxifloxacin Hydrochloride Monohydrate
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL
Pharmacologic Class
Usage Information
This medication is a quinolone antibiotic used for eye infections.

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090080
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2023
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 80425-0239-1 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 3 ml in 1 bottle, dropper of Moxifloxacin, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This solution/ drops is formulated for ophthalmic use and contains moxifloxacin hydrochloride monohydrate 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 Advanced Rx Pharmacy Of Tennessee, Llc on January 11, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a quinolone antibiotic used for eye infections.

How is this Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425023901. 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 (5-4-1)
80425-0239-1
11-Digit CMS (5-4-2)
80425-0239-01

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