This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.
NDC Package Code:
10337-815-06
Package Description:
60 CAPSULE in 1 BOTTLE
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the
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 Chlamydia 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 (formerly Pasteurella pestis).
Tularemia due to Francisella tularensis
(formerly Pasteurella tularensis).
Cholera caused by
Vibrio cholerae (formerly Vibrio comma).
Campylobacter fetus infections caused by
Campylobacter fetus (formerly Vibrio 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 (formerly Aerobacter aerogenes)
Shigella species
Acinetobacter species (formerly Mima
species and Herellea species)
Respiratory tract infections caused by
Haemophilus influenzae.
Respiratory tract and urinary 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 (formerly Diplococcus pneumoniae).
Upper respiratory infections caused by Streptococcus pneumoniae (formerly
Diplococcus pneumoniae).
Skin and skin structure infections caused by Staphylococcus aureus.
Anthrax due to Bacillus anthracis,
including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to
aerosolized Bacillus anthracis.
Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.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.
11-Digit NDC Billing Format:
10337081506
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
Labeler Name:
Fougera Pharmaceuticals Inc.
FDA Application Number:
ANDA065055
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-01-2011
End Marketing Date:
05-31-2016
Listing Expiration Date:
05-31-2016
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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