Tetracycline Hydrochloride
NDC Package 53808-0877-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Tetracycline Hydrochloride is 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. Marketed by State Of Florida Doh Central Pharmacy, this product is identified by NDC 53808-0877 and is authorized under FDA application ANDA061837.

Identification & Billing

NDC Package Code
53808-0877-2
Package Description
60 CAPSULE in 1 BLISTER PACK
Product Code
53808-0877
11-Digit Billing Format
53808087702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tetracycline Hydrochloride
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
State Of Florida Doh Central Pharmacy
FDA Application #
ANDA061837
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2013
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53808-0877-2 identifies a specific commercial package of 60 capsule in 1 blister pack of Tetracycline Hydrochloride, labeled by State Of Florida Doh Central Pharmacy. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by State Of Florida Doh Central Pharmacy on January 01, 2013. The current certification is valid through December 31, 2017.

How is this State Of Florida Doh Central Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53808087702. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
53808-0877-2
11-Digit CMS (5-4-2)
53808-0877-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.