Tetracycline Hydrochloride
NDC 53808-0877

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53808-0877?
  5. Tetracycline Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tetracycline Hydrochloride is a ANDA-approved product labeled by State Of Florida Doh Central Pharmacy. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow product. This product entry covers the primary NDC 53808-0877 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53808-0877
Proprietary Name:
Tetracycline Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
State Of Florida Doh Central Pharmacy
Labeler Code:
53808
Product Label ID:
edf54a38-41a7-42ec-a05f-46ab20cb6fc3
FDA Application Number: [6]
ANDA061837
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-01-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW OPAQUE BODY)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
WPI;2235
Score:
1

Code Structure Chart

Product Details

What is NDC 53808-0877?

The NDC code 53808-0877 is assigned by the FDA to the product Tetracycline Hydrochloride. This pharmaceutical product is labeled by State Of Florida Doh Central Pharmacy and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 53808-0877-2. 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?

Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Upper respiratory tract infections caused by Streptococcuspyogenes, Streptococcuspneumoniae and Hemophilusinfluenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.Lower respiratory tract infections caused by Streptococcuspyogenes, Streptococcuspneumoniae, Mycoplasmapneumoniae (Eaton agent, and Klebsiellasp.)Skin and soft tissue infections caused by Streptococcuspyogenes, Staphylococcusaureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.Psittacosis of ornithosis caused by Chlamydiapsittaci.Infections caused by Chlamydiatrachomatis such as uncomplicated urethral, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.Granuloma inquinale caused by Calymmatobacteriumgranulomatis.Relapsing fever caused by Borrelia sp.Bartonellosis caused by Bartonellabacilli-formis.Chancroid caused by Hemophilus ducreyi.Tularemia caused by Francisella tularensis.Plaque caused by Yersiniapestis.Cholera caused by Vibriocholerae.Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).Infections due to Campylobacterfetus.As adjunctive therapy in intestinal amebiasis caused by Entamoebahistolytica.Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacteraerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.In severe acne, adjunctive therapy with tetracycline may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:syphilis and yaws caused by Treponema pallidumand pertenue, respectively,Vincent’s infection caused by Fusobacterium fusiforme,infections caused by Neisseria gonorrhoeae,anthrax caused by Bacillus anthracis,infections due to Listeria monocytogenes,actinomycosis caused by Actinomyces species,infections due to Clostridium species.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 198252 - tetracycline HCl 500 MG Oral Capsule
  • RxCUI: 198252 - tetracycline hydrochloride 500 MG Oral Capsule
  • RxCUI: 198252 - tetracycline (as tetracycline hydrochloride) 500 MG Oral Capsule

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Product & Regulatory Definitions
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".