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NDC Package Code:
51655-753-25
Package Description:
60 CAPSULE in 1 BOTTLE, PLASTIC
Proprietary Name:
Minocycline Hydrochloride
Non-Proprietary Name:
Minocycline Hydrochloride
Substance Name:
Minocycline Hydrochloride
Usage Information:
Minocycline hydrochloride capsules USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: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) due to
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.
Nongonococcal urethritis, endocervical, or rectal infections 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
Klebsiella granulomatis.
Minocycline is indicated for the 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.
Minocycline hydrochloride capsules USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by
Streptococcus pneumoniae.
Skin and skin structure infections caused by
Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:Uncomplicated urethritis in men due to
Neisseria gonorrhoeae and for the treatment of other 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.
Infections caused by
Clostridium species.
In
acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.
In severe
acne, minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of
Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by
Mycobacterium marinum.To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules USP and other antibacterial drugs, minocycline hydrochloride capsules 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:
51655075325
Product Type:
Human Prescription Drug
Labeler Name:
Northwind Pharmaceuticals, Llc
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.
FDA Application Number:
ANDA063011
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-24-2023
Listing Expiration Date:
12-31-2025
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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