Demeclocycline Hydrochloride
NDC Package 68151-0155-1

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.

Demeclocycline Hydrochloride is to reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride tablets 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. Marketed by Carilion Materials Management, this product is identified by NDC 68151-0155 and is authorized under FDA application ANDA065425.

Identification & Billing

NDC Package Code
68151-0155-1
Package Description
1 TABLET in 1 PACKAGE
Product Code
68151-0155
11-Digit Billing Format
68151015501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Demeclocycline Hydrochloride
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride tablets 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. Demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae; Respiratory tract infections caused by ; Lymphogranuloma venereum due to ; Psittacosis (Ornithosis) due to ; Trachoma due to , although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by ; Nongonococcal urethritis in adults caused by or ; Relapsing fever due to ; Chancroid caused by ; Plague due to ; Tularemia due to ; Cholera caused by ; Campylobacter fetus infections caused by ; Brucellosis due to species (in conjunction with streptomycin); Bartonellosis due to ; Granuloma inguinale caused by ; Demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: ; ; species; species; Respiratory tract infections caused by ; Respiratory tract and urinary tract infections caused by species. Demeclocycline hydrochloride is 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 pneumoniae; Skin and skin structure infections caused by . (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections: Uncomplicated urethritis in men due to , and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by ; Syphilis caused by subspecies ; Yaws caused by subspecies ; Listeriosis due to ; Anthrax due to ; Vincent’s infection caused by ; Actinomycosis caused by ; Clostridial diseases caused by species. In acute intestinal amebiasis, demeclocycline hydrochloride may be a useful adjunct to amebicides. In severe acne, demeclocycline hydrochloride may be a useful adjunctive therapy. Mycoplasma pneumoniaeChlamydia trachomatisChlamydia psittaciChlamydia trachomatisChlamydia trachomatisUreaplasma urealyticumChlamydia trachomatisBorrelia recurrentisHaemophilus ducreyiYersinia pestisFrancisella tularensisVibrio choleraeCampylobacter fetusBrucellaBartonella bacilliformisCalymmatobacterium granulomatisEscherichia coliEnterobacter aerogenesShigellaAcinetobacterHaemophilus influenzaeKlebsiellaStreptococcusStaphylococcus aureusNeisseria gonorrhoeaeNeisseria gonorrhoeaeTreponema pallidumpallidumTreponema pallidumpertenueListeria monocytogenesBacillus anthracisFusobacterium fusiformeActinomyces israeliiClostridium

Regulatory & Marketing

Labeler Name
Carilion Materials Management
FDA Application #
ANDA065425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2010
Listing Expiration
12-31-2018
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 68151-0155-1 identifies a specific commercial package of 1 tablet in 1 package of Demeclocycline Hydrochloride, labeled by Carilion Materials Management. 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 Carilion Materials Management on April 01, 2010. The current certification is valid through December 31, 2018.

How is this Carilion Materials Management product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68151015501. 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)
68151-0155-1
11-Digit CMS (5-4-2)
68151-0155-01

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