Doxycycline Hyclate capsules is to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a capsule delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4658 and is authorized under FDA application ANDA062396.
Identification & Billing
NDC Package Code
70518-4658-0
Package Description
6 CAPSULE in 1 BOTTLE, PLASTIC
11-Digit Billing Format
70518465800
Clinical Specifications
Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
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
Oral - Administration to or by way of the mouth.
Usage Information
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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
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
Vibriocholerae.Campylobacter fetus infections caused by
Campylobacter fetus.
Brucellosis due to
Brucellaspecies(in conjunction with streptomycin).
Bartonellosis due to
Bartonella bacilliformis.
Granuloma inguinale caused by
Klebsiellagranulomatis.
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 bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli.Enterobacter aerogenes.
Shigellaspecies.
Acinetobacterspecies.
Respiratory tract infections caused by
Haemophilus influenzae.
Respiratory tract and urinary tract infections caused by
Klebsiellaspecies.
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
Treponemapallidumsubspecies
pertenue.
Listeriosis due to
Listeriamonocytogenes.
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. Doxycycline is indicated for the prophylaxis of malaria due to
Plasmodium falciparumin short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains (See
DOSAGE AND ADMINISTRATIONsection and
Information for Patientssubsection of the
PRECAUTIONSsection).
Regulatory & Marketing
Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA062396
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-13-2026
Listing Expiration
12-31-2027
Hierarchy Structure
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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