Demeclocycline Hydrochloride Tablet
NDC Package 60687-705-65

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

Package Information

Demeclocycline Hydrochloride (demeclocycline) tablets is demeclocycline hydrochloride tablets are 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 pneumoniaeLymphogranuloma venereum due to Chlamydia trachomatisPsittacosis (Ornithosis) due to Chlamydia psittaciTrachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence Inclusion conjunctivitis caused by Chlamydia trachomatisNongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatisRelapsing fever due to Borrelia recurrentisChancroid caused by Haemophilus ducreyiPlague due to Yersinia pestisTularemia due to Francisella tularensisCholera caused by Vibrio choleraeCampylobacter fetus infections cause by Campylobacter fetusBrucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformisGranuloma inguinale caused by Calymmatobacterium granulomatisDemeclocycline hydrochloride tablets are indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coliEnterobacter aerogenesShigella species Acinetobacter species Respiratory tract infections caused by Haemophilus influenzaeRespiratory tract and urinary tract infections caused by Klebsiella species Demeclocycline hydrochloride tablets are 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 pneumoniaeSkin and skin structure infections caused by Staphylococcus aureus. This formulation utilizes a tablet delivery system. Marketed by American Health Packaging, this product is identified by NDC 60687-705 and is authorized under FDA application ANDA065425.

Identification & Billing

NDC Package Code
60687-705-65
Package Description
50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (60687-705-11)
Product Code
60687-705
11-Digit Billing Format
60687070565
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Demeclocycline Hydrochloride
Non-Proprietary Name
Demeclocycline
Substance Name
Demeclocycline Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1
Pharmacologic Class
Usage Information
Demeclocycline hydrochloride tablets are 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 pneumoniaeLymphogranuloma venereum due to Chlamydia trachomatisPsittacosis (Ornithosis) due to Chlamydia psittaciTrachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence Inclusion conjunctivitis caused by Chlamydia trachomatisNongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatisRelapsing fever due to Borrelia recurrentisChancroid caused by Haemophilus ducreyiPlague due to Yersinia pestisTularemia due to Francisella tularensisCholera caused by Vibrio choleraeCampylobacter fetus infections cause by Campylobacter fetusBrucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformisGranuloma inguinale caused by Calymmatobacterium granulomatisDemeclocycline hydrochloride tablets are indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coliEnterobacter aerogenesShigella species Acinetobacter species Respiratory tract infections caused by Haemophilus influenzaeRespiratory tract and urinary tract infections caused by Klebsiella species Demeclocycline hydrochloride tablets are 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 pneumoniaeSkin 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 gonorrhoeaeSyphilis caused by Treponema pallidum subspecies pallidum Yaws caused by Treponema pallidum subspecies pertenue Listeriosis due to Listeria monocytogenesAnthrax due to Bacillus anthracisVincent’s infection caused by Fusobacterium fusiformeActinomycosis caused by Actinomyces israeliiClostridial diseases caused by Clostridium 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.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.

Regulatory & Marketing

Labeler Name
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA065425
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2023
Listing Expiration
12-31-2026
Exclude Flag
N
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 60687-705-65 identifies a specific commercial package of 50 blister pack in 1 carton / 1 tablet in 1 blister pack (60687-705-11) of Demeclocycline Hydrochloride, a human prescription drug labeled by American Health Packaging. This tablet is formulated for oral use and contains demeclocycline hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by American Health Packaging on January 19, 2023. The current certification is valid through December 31, 2026.

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60687070565. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 total billable units per package. 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 (5-3-2)
60687-705-65
11-Digit CMS (5-4-2)
60687-0705-65

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