NDC 71335-2109 Doxycycline

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 71335-2109 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
71335-2109
Proprietary Name:
Doxycycline
Product Type: [3]
Labeler Code:
71335
FDA Application Number: [6]
ANDA065285
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
12-08-2005
End Marketing Date: [10]
08-26-2024
Listing Expiration Date: [11]
08-26-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
LCI;1338
Score:
1

Code Structure Chart

Product Details

What is NDC 71335-2109?

The NDC code 71335-2109 is assigned by the FDA to the product Doxycycline which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 10 packages with assigned NDC codes 71335-2109-0 2 tablet, film coated in 1 bottle, plastic , 71335-2109-1 30 tablet, film coated in 1 bottle, plastic , 71335-2109-2 14 tablet, film coated in 1 bottle, plastic , 71335-2109-3 20 tablet, film coated in 1 bottle, plastic , 71335-2109-4 12 tablet, film coated in 1 bottle, plastic , 71335-2109-5 40 tablet, film coated in 1 bottle, plastic , 71335-2109-6 10 tablet, film coated in 1 bottle, plastic , 71335-2109-7 50 tablet, film coated in 1 bottle, plastic , 71335-2109-8 21 tablet, film coated in 1 bottle, plastic , 71335-2109-9 60 tablet, film coated in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Doxycycline?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets, USP and other antibacterial drugs, doxycycline tablets, 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 Tablets, 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 Tablets, 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 Tablets, USP are 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     Shigella species     Acinetobacter species     Respiratory tract infections caused by Haemophilus influenzae.     Respiratory tract and urinary tract infections caused by Klebsiella species.Doxycycline Tablets, 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 subspecies pertenue. 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.

Which are Doxycycline UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Doxycycline Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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".