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  4. NDC Product Code: 53808-0877 Tetracycline Hydrochloride

NDC 53808-0877 Tetracycline Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

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.

Get all the details for National Drug Code (NDC) 53808-0877 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:
53808-0877
Proprietary Name:
Tetracycline Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
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.
Start Marketing Date: [9]
01-01-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

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 which is product labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53808-0877-2 60 capsule in 1 blister pack . 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 Tetracycline Hydrochloride?

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 Tetracycline Hydrochloride UNII Codes?

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

Which are Tetracycline Hydrochloride 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:

What is the NDC to RxNorm Crosswalk for Tetracycline Hydrochloride?

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

* Please review the disclaimer below.

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.

[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".