Moxifloxacin Hydrochloride Solution
NDC Package 76420-331-03

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

Package Information

Moxifloxacin Hydrochloride solution is moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacteriumspecies Efficacy for this organism was studied in fewer than 10 infections.Micrococcus luteus Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii Haemophilus influenza Haemophilus parainfluenzae Chlamydia trachomatis. This formulation utilizes a solution delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-331 and is authorized under FDA application ANDA212616.

Identification & Billing

NDC Package Code
76420-331-03
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 3 mL in 1 BOTTLE, PLASTIC
Product Code
76420-331
11-Digit Billing Format
76420033103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Moxifloxacin Hydrochloride
Non-Proprietary Name
Moxifloxacin Hydrochloride
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
Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacteriumspecies Efficacy for this organism was studied in fewer than 10 infections.Micrococcus luteus Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii Haemophilus influenza Haemophilus parainfluenzae Chlamydia trachomatis

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212616
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-2021
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 76420-331-03 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 3 ml in 1 bottle, plastic of Moxifloxacin Hydrochloride, a human prescription drug labeled by Asclemed Usa, 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 Asclemed Usa, Inc. on February 10, 2021. The current certification is valid through December 31, 2026.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420033103. 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)
76420-331-03
11-Digit CMS (5-4-2)
76420-0331-03

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