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NDC Package Code:
62135-725-20
Package Description:
20 TABLET in 1 BOTTLE
Proprietary Name:
Doxycycline
Non-Proprietary Name:
Doxycycline
Substance Name:
Doxycycline
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 coliEnterobacter aerogenesShigella speciesAcinetobacter speciesRespiratory 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 pallidum subspecies
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.
11-Digit NDC Billing Format:
62135072520
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
Product Type:
Human Prescription Drug
Labeler Name:
Chartwell Rx, Llc
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
FDA Application Number:
ANDA091605
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-01-2012
Listing Expiration Date:
12-31-2024
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