Zithromax Injection, Powder, Lyophilized, For Solution
NDC Package 0069-0400-10

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

Package Information

Zithromax (azithromycin dihydrate) injection is azithromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-0400 and is authorized under FDA application NDA050733.

Identification & Billing

NDC Package Code
0069-0400-10
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL (0069-0400-01)
Product Code
0069-0400
11-Digit Billing Format
00069040010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zithromax
Non-Proprietary Name
Azithromycin Dihydrate
Substance Name
Azithromycin Dihydrate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AZITHROMYCIN DIHYDRATE 500 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
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA050733
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-07-2014
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 0069-0400-10 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial (0069-0400-01) of Zithromax, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains azithromycin dihydrate 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 Pfizer Laboratories Div Pfizer Inc on March 07, 2014. 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 Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069040010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (4-4-2)
0069-0400-10
11-Digit CMS (5-4-2)
00069-0400-10

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