NDC 21695-640 Tetracycline Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
21695-640
Proprietary Name:
Tetracycline Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Start Marketing Date: [9]
03-23-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE OPAQUE)
YELLOW (C48330 - YELLOW OPAQUE)
BLACK (C48323)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
22 MM
Imprint(s):
2416
2407
Score:
1

Product Packages

NDC Code 21695-640-28

Package Description: 28 CAPSULE in 1 BOTTLE

NDC Code 21695-640-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 21695-640-40

Package Description: 40 CAPSULE in 1 BOTTLE

NDC Code 21695-640-42

Package Description: 42 CAPSULE in 1 BOTTLE

NDC Code 21695-640-56

Package Description: 56 CAPSULE in 1 BOTTLE

NDC Code 21695-640-90

Package Description: 90 CAPSULE in 1 BOTTLE

Product Details

What is NDC 21695-640?

The NDC code 21695-640 is assigned by the FDA to the product Tetracycline Hydrochloride which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 21695-640-28 28 capsule in 1 bottle , 21695-640-30 30 capsule in 1 bottle , 21695-640-40 40 capsule in 1 bottle , 21695-640-42 42 capsule in 1 bottle , 21695-640-56 56 capsule in 1 bottle , 21695-640-90 90 capsule in 1 bottle . 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?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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.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 Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (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 or ornithosis caused by Chlamydia Psittaci.Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.Granuloma inquinale caused by Calymmatobacterium granulomatis.Relapsing fever caused by Borrelia sp.Bartonellosis caused by Bartonella bacilliformis.Chancroid caused by Hemophilus ducreyi.Tularemia caused by Francisella tularensis.Plaque caused by Yersinia pestis.Cholera caused by Vibrio cholerae.Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).Infections due to Campylobacter fetus.As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, 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 pallidum and 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:

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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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".