Azasite Solution/ Drops
NDC Package 82584-307-03

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

Azasite (azithromycin monohydrate) solution/ dropses is a medication used to treat certain eye infections. This formulation utilizes a solution/ drops delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-307 and is authorized under FDA application NDA050810.

Identification & Billing

NDC Package Code
82584-307-03
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER
Product Code
82584-307
11-Digit Billing Format
82584030703
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azasite
Non-Proprietary Name
Azithromycin Monohydrate
Substance Name
Azithromycin 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)
AZITHROMYCIN MONOHYDRATE 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Thea Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050810
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82584-307). Click a package code to view its specific billing and regulatory data.

82584-307-02
1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER

* 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 82584-307-03 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 2.5 ml in 1 bottle, dropper of Azasite, a human prescription drug labeled by Thea Pharma Inc.. This solution/ drops is formulated for ophthalmic use and contains azithromycin 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 Thea Pharma Inc. on November 01, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Thea Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584030703. 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 (5-3-2)
82584-307-03
11-Digit CMS (5-4-2)
82584-0307-03

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