Zmax
NDC Package 21695-444-60

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

Package Information

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

Zmax is indicated for the treatment with mild to moderate infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-444 and is authorized under FDA application NDA050797.

Identification & Billing

NDC Package Code
21695-444-60
Package Description
60 mL in 1 BOTTLE
Product Code
21695-444
11-Digit Billing Format
21695044460
RxNorm Crosswalk
  • RxCUI: 577378 - azithromycin 2 GM in 60 mL Extended Release Oral Suspension
  • RxCUI: 577378 - azithromycin 33.3 MG/ML Extended Release Suspension
  • RxCUI: 577378 - azithromycin 2 GM per 60 ML Extended Release Suspension
  • RxCUI: 583482 - Zmax 2 GM in 60 mL Extended Release Oral Suspension
  • RxCUI: 583482 - azithromycin 33.3 MG/ML Extended Release Suspension [Zmax]

Clinical Specifications

Proprietary Name
Zmax
Dosage Form
-
Usage Information
Zmax is indicated for the treatment with mild to moderate infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. [See CLINICAL STUDIES (14)]Acute bacterial sinusitis in adults due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.Community-acquired pneumonia in adults and pediatric patients six months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy. [See USE IN SPECIFIC POPULATIONS (8.4)]To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zmax and other antibacterial drugs, Zmax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Zmax. [See Clinical Pharmacology (12.4)] Therapy with Zmax may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
NDA050797
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-10-1995
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21695-444-60 identifies a specific commercial package of 60 ml in 1 bottle of Zmax, labeled by Rebel Distributors Corp. 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 Rebel Distributors Corp on June 10, 1995. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695044460. 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)
21695-444-60
11-Digit CMS (5-4-2)
21695-0444-60

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