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NDC Package Code:
67296-2083-2
Package Description:
20 CAPSULE 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 capsules and other antibacterial drugs, doxycycline capsules 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
Chlamydophilapsittaci.
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
Klebsiella 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
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 pallidumsubspecies
pertenue.
Listeriosis due to
Listeria monocytogenes.Vincent's infection caused by
Fusobacterium fusiforme.Actinomycosis caused by
Actinomyces israelii.
Infections caused by
Clostridiumspecies.
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:
67296208302
Product Type:
Human Prescription Drug
Labeler Name:
Redpharm Drug
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Oral - Administration to or by way of the mouth.
FDA Application Number:
ANDA065055
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-01-2022
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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