Azithromycin Dihydrate
NDC Package 50436-2852-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Azithromycin Dihydrate is azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Marketed by Unit Dose Services, this product is identified by NDC 50436-2852 and is authorized under FDA application ANDA065509.

Identification & Billing

NDC Package Code
50436-2852-2
Package Description
2 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-2852
11-Digit Billing Format
50436285202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azithromycin Dihydrate
Dosage Form
-
Usage Information
Azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)]. 

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA065509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-18-2011
Listing Expiration
12-31-2019
Exclude Flag
I
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 (50436-2852). Click a package code to view its specific billing and regulatory data.

50436-2852-1
1 TABLET, FILM COATED in 1 BOTTLE

* 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 50436-2852-2 identifies a specific commercial package of 2 tablet, film coated in 1 bottle of Azithromycin Dihydrate, labeled by Unit Dose Services. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unit Dose Services on July 18, 2011. The current certification is valid through December 31, 2019.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436285202. 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)
50436-2852-2
11-Digit CMS (5-4-2)
50436-2852-02

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