Moxifloxacin Solution
NDC Package 68180-421-01

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

Package Information

Moxifloxacin solution is a medication a quinolone antibiotic used for eye infections. This formulation utilizes a solution delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-421 and is authorized under FDA application ANDA204079.

Identification & Billing

NDC Package Code
68180-421-01
Package Description
3 mL in 1 BOTTLE
Product Code
68180-421
11-Digit Billing Format
68180042101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
3 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Moxifloxacin
Non-Proprietary Name
Moxifloxacin
Substance Name
Moxifloxacin Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
This medication is a quinolone antibiotic used for eye infections.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204079
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2020
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 68180-421-01 identifies a specific commercial package of 3 ml in 1 bottle of Moxifloxacin, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This solution is formulated for ophthalmic use and contains moxifloxacin hydrochloride 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 February 13, 2020. 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 Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180042101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 3 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)
68180-421-01
11-Digit CMS (5-4-2)
68180-0421-01

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