Doxycycline Capsule
NDC 67296-2344
Doxycycline 50 mg/1 · Capsule (oral)
Product Information
Doxycycline is a ANDA-approved product labeled by Redpharm Drug. This medication is typically used as a tetracycline-class drug [epc]. It is supplied as a capsule for oral administration. This product entry covers the primary NDC 67296-2344 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
67296-2344
Proprietary Name:
Doxycycline
Non-Proprietary Name: [1]
Doxycycline
Substance Name: [2]
Doxycycline
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
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): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
67296
Product Label ID:
FDA Application Number: [6]
ANDA205115
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-14-2016
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 67296-2344?
The NDC code 67296-2344 is assigned by the FDA to the product Doxycycline. This pharmaceutical product is labeled by Redpharm Drug and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 67296-2344-2, 67296-2344-4. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline 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.Doxycycline capsules, USP are 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 capsules, USP are 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 capsules, USP are 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 capsules, USP are 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
Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.In severe acne, doxycycline may be useful adjunctive therapy.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- DOXYCYCLINE 50 mg/1 - A synthetic tetracycline derivative with similar antimicrobial activity.
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
