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  5. NDC Package Code: 82584-307-02 Azasite

NDC Package 82584-307-02 Azasite

Azithromycin Monohydrate Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
82584-307-02
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER
Product Code:
82584-307
Proprietary Name:
Azasite
Non-Proprietary Name:
Azithromycin Monohydrate
Substance Name:
Azithromycin Monohydrate
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.
11-Digit NDC Billing Format:
82584030702
NDC to RxNorm Crosswalk:
  • RxCUI: 706868 - azithromycin 1 % Ophthalmic Solution
  • RxCUI: 706868 - azithromycin 10 MG/ML Ophthalmic Solution
  • RxCUI: 706868 - azithromycin (as azithromycin monohydrate) 10 MG/ML Ophthalmic Solution
  • RxCUI: 706872 - AzaSite 1 % Ophthalmic Solution
  • RxCUI: 706872 - azithromycin 10 MG/ML Ophthalmic Solution [AzaSite]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Thea Pharma Inc.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • AZITHROMYCIN MONOHYDRATE 10 mg/mL
    • Pharmacologic Class(es):
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    Yes
    FDA Application Number:
    NDA050810
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-01-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    82584-307-031 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 82584-307-02?

    The NDC Packaged Code 82584-307-02 is assigned to a 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.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 82584-307 included in the NDC Directory?

    Yes, Azasite with product code 82584-307 is active and included in the NDC Directory. The product was first marketed by Thea Pharma Inc. on November 01, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 82584-307-02?

    The 11-digit format is 82584030702. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-282584-307-025-4-282584-0307-02