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NDC Package Code:
42806-143-05
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE
Proprietary Name:
Demeclocycline Hydrochloride
Non-Proprietary Name:
Demeclocycline Hydrochloride
Substance Name:
Demeclocycline Hydrochloride
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.
11-Digit NDC Billing Format:
42806014305
Product Type:
Human Prescription Drug
Labeler Name:
Epic Pharma, Llc
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
FDA Application Number:
ANDA065447
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-02-2015
Listing Expiration Date:
12-31-2024
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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