Demeclocycline Hydrochloride
NDC Package 10135-626-48

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.

Demeclocycline Hydrochloride is tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: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 due to Chlamydia trachomatis; Psittacosis (Ornithosis) due to Chlamydia psittaci; Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia  trachomatis; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis; Relapsing fever due to Borrelia recurrentis;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;Demeclocycline hydrochloride tablets USP 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.Demeclocycline hydrochloride tablets USP 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; Skin and skin structure infections caused by Staphylococcus aureus.(Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections:Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae;Syphilis caused by Treponema pallidum subspecies pallidum; Yaws caused by Treponema pallidum subspecies pertenue; Listeriosis due to Listeria monocytogenes;Anthrax due to Bacillus anthracis;Vincent’s infection caused by Fusobacterium fusiforme; Actinomycosis caused by Actinomyces israelii; Clostridial diseases caused by Clostridium species.In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides.In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive  therapy.To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-626 and is authorized under FDA application ANDA065447.

Identification & Billing

NDC Package Code
10135-626-48
Package Description
48 TABLET, FILM COATED in 1 BOTTLE
Product Code
10135-626
11-Digit Billing Format
10135062648
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
48 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Demeclocycline Hydrochloride
Dosage Form
-
Usage Information
Demeclocycline hydrochloride tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: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 due to Chlamydia trachomatis; Psittacosis (Ornithosis) due to Chlamydia psittaci; Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia  trachomatis; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis; Relapsing fever due to Borrelia recurrentis;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;Demeclocycline hydrochloride tablets USP 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.Demeclocycline hydrochloride tablets USP 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; Skin and skin structure infections caused by Staphylococcus aureus.(Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections:Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae;Syphilis caused by Treponema pallidum subspecies pallidum; Yaws caused by Treponema pallidum subspecies pertenue; Listeriosis due to Listeria monocytogenes;Anthrax due to Bacillus anthracis;Vincent’s infection caused by Fusobacterium fusiforme; Actinomycosis caused by Actinomyces israelii; Clostridial diseases caused by Clostridium species.In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides.In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive  therapy.To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets USP 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.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
FDA Application #
ANDA065447
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2016
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-626-48 identifies a specific commercial package of 48 tablet, film coated in 1 bottle of Demeclocycline Hydrochloride, labeled by Marlex Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 48 billable units per package. 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 Marlex Pharmaceuticals Inc on July 01, 2016. The current certification is valid through December 31, 2017.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135062648. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 48 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 (5-3-2)
10135-626-48
11-Digit CMS (5-4-2)
10135-0626-48

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