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  5. NDC Package Code: 65162-554-10 Demeclocycline Hydrochloride

NDC Package 65162-554-10 Demeclocycline Hydrochloride

Demeclocycline Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
65162-554-10
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
65162-554
Proprietary Name:
Demeclocycline Hydrochloride
Non-Proprietary Name:
Demeclocycline
Substance Name:
Demeclocycline Hydrochloride
Usage Information:
Demeclocycline HCl tablets, USP 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 immunofluorescenceInclusion conjunctivitis caused by Chlamydia trachomatisNongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis Relapsing 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 HCl tablets, USP are indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli Enterobacter aerogenes Shigella speciesAcinetobacter speciesRespiratory tract infections caused by Haemophilus influenzaeRespiratory tract and urinary tract infections caused by Klebsiella speciesDemeclocycline HCl tablets, USP 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 HCl, USP, 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 infectionsInfections in women caused by Neisseria gonorrhoeaeSyphilis caused by Treponema pallidum subspecies pallidumYaws caused by Treponema pallidum subspecies pertenueListeriosis due to Listeria monocytogenesAnthrax due to Bacillus anthracisVincent’s infection caused by Fusobacterium fusiformeActinomycosis caused by Actinomyces israeliiClostridial diseases caused by Clostridium speciesIn acute intestinal amebiasis, demeclocycline HCl, USP may be a useful adjunct to amebicides.In severe acne, demeclocycline HCl, USP may be a useful adjunctive therapy.To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline HCl tablets, USP and other antibacterial drugs, demeclocycline HCl 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:
65162055410
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1
    • Pharmacologic Class(es):
  • Tetracycline-class Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA065425
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-27-2008
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 65162-554-10?

    The NDC Packaged Code 65162-554-10 is assigned to a package of 100 tablet in 1 bottle of Demeclocycline Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65162-554 included in the NDC Directory?

    Yes, Demeclocycline Hydrochloride with product code 65162-554 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on February 27, 2008 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65162-554-10?

    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 65162-554-10?

    The 11-digit format is 65162055410. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265162-554-105-4-265162-0554-10