NDC Package 10135-625-01 Demeclocycline Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

10135-625-01

Package Description:

100 TABLET, FILM COATED in 1 BOTTLE

Product Code:

10135-625

Proprietary Name:

Demeclocycline Hydrochloride

Usage Information:

Demeclocycline hydrochloride tablets USP 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 Mycoplasma pneumoniae; Lymphogranuloma venereum due to Chlamydia trachomatis; Psittacosis (Ornithosis) due to Chlamydia psittaci; Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia trachomatis; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis; Relapsing fever due to Borrelia recurrentis;Chancroid caused by Haemophilus ducreyi; Plague due to Yersinia pestis;Tularemia due to Francisella tularensis; Cholera caused by Vibrio cholerae;Campylobacter fetus infections caused by Campylobacter fetus; Brucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformis;Granuloma inguinale caused by Calymmatobacterium granulomatis;Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species;Respiratory tract infections caused by Haemophilus influenzae; Respiratory tract and urinary tract infections caused by Klebsiella species.Demeclocycline hydrochloride tablets USP 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 Streptococcus pneumoniae; Skin and skin structure infections caused by Staphylococcus aureus.(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 Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae;Syphilis caused by Treponema pallidum subspecies pallidum; Yaws caused by Treponema pallidum subspecies pertenue; Listeriosis due to Listeria monocytogenes;Anthrax due to Bacillus anthracis;Vincent’s infection caused by Fusobacterium fusiforme; Actinomycosis caused by Actinomyces israelii; Clostridial diseases caused by Clostridium species.In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides.In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive therapy.To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets USP 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.

11-Digit NDC Billing Format:

10135062501

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

NDC to RxNorm Crosswalk:

RxCUI: 905341 - demeclocycline HCl 150 MG Oral Tablet

RxCUI: 905341 - demeclocycline hydrochloride 150 MG Oral Tablet

RxCUI: 905347 - demeclocycline HCl 300 MG Oral Tablet

RxCUI: 905347 - demeclocycline hydrochloride 300 MG Oral Tablet

Labeler Name:

Marlex Pharmaceuticals Inc

Sample Package:

Start Marketing Date:

07-01-2016

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

10135 - Marlex Pharmaceuticals Inc
- 10135-625 - Demeclocycline Hydrochloride
  - 10135-625-01 - 100 TABLET, FILM COATED in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 10135-625-01?

The NDC Packaged Code 10135-625-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Demeclocycline Hydrochloride, labeled by Marlex Pharmaceuticals Inc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 10135-625 included in the NDC Directory?

No, Demeclocycline Hydrochloride with product code 10135-625 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Marlex Pharmaceuticals Inc on July 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 10135-625-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 10135-625-01?

The 11-digit format is 10135062501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	10135-625-01	5-4-2	10135-0625-01

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