Azithromycin Powder, For Suspension
NDC Package 55695-003-00

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

Azithromycin powders is azithromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a powder, for suspension delivery system. Marketed by State Health Services, Texas Department Of, this product is identified by NDC 55695-003 and is authorized under FDA application ANDA065246.

Identification & Billing

NDC Package Code
55695-003-00
Package Description
30 mL in 1 BOTTLE
Product Code
55695-003
11-Digit Billing Format
55695000300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azithromycin
Non-Proprietary Name
Azithromycin
Substance Name
Azithromycin Monohydrate
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AZITHROMYCIN MONOHYDRATE 200 mg/5mL
Pharmacologic Class
Usage Information
Azithromycin is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
State Health Services, Texas Department Of
Product Type
Human Prescription Drug
FDA Application #
ANDA065246
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2010
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 (55695-003). Click a package code to view its specific billing and regulatory data.

55695-003-01
15 mL 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 55695-003-00 identifies a specific commercial package of 30 ml in 1 bottle of Azithromycin, a human prescription drug labeled by State Health Services, Texas Department Of. This powder, for suspension is formulated for oral 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 State Health Services, Texas Department Of on December 17, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Azithromycin is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this State Health Services, Texas Department Of product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55695000300. 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)
55695-003-00
11-Digit CMS (5-4-2)
55695-0003-00

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