Nicazeldoxykit
NDC Package 42783-601-30

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 discontinued by the firm.

Nicazeldoxykit is to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Elorac, Inc., this product is identified by NDC 42783-601 and is authorized under FDA application ANDA065285.

Identification & Billing

NDC Package Code
42783-601-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
42783-601
11-Digit Billing Format
42783060130
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicazeldoxykit
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent 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.Doxycycline is indicated for the treatment of the following infections:  Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis.Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Calymmatobacterium granulomatis.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli  Enterobacter aerogenes  Shigella species Acinetobacter species  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species.Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of                        disease following exposure to aerosolized Bacillus anthracis.When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:  Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent's infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.In severe acne, doxycycline may be useful adjunctive therapy.

Regulatory & Marketing

Labeler Name
Elorac, Inc.
FDA Application #
ANDA065285
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2005
End Marketing Date
08-12-2014
Listing Expiration
08-12-2014
Exclude Flag
D
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 (42783-601). Click a package code to view its specific billing and regulatory data.

42783-601-60
60 TABLET, FILM COATED in 1 BOTTLE
42783-601-60
60 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 42783-601-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Nicazeldoxykit, labeled by Elorac, Inc.. 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 Elorac, Inc. on December 08, 2005. The current certification is valid through August 12, 2014.

How is this Elorac, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42783060130. 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)
42783-601-30
11-Digit CMS (5-4-2)
42783-0601-30

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