NDC Package 59651-337-01 Minocycline Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
59651-337-01
Package Description:
100 TABLET, FILM COATED in 1 CONTAINER
Product Code:
Proprietary Name:
Minocycline Hydrochloride
Non-Proprietary Name:
Minocycline Hydrochloride
Substance Name:
Minocycline Hydrochloride
Usage Information:
Minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: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 caused by Chlamydia trachomatis.Psittacosis (Ornithosis) due to Chlamydia psittaci.Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis.Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.Relapsing fever due to Borrelia recurrentis.Chancroid caused by Haemophilus ducreyiPlague 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.Minocycline 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 infection caused by Haemophilus influenzae.Respiratory tract and urinary tract infections caused by Klebsiella species.Minocycline hydrochloride tablets are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniaeSkin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other 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.Infections caused by Clostridium species.In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.In severe acne, minocycline may be useful adjunctive therapy.Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.Oral minocycline is not indicated for the treatment of meningococcal infection.Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline 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.
11-Digit NDC Billing Format:
59651033701
NDC to RxNorm Crosswalk:
  • RxCUI: 207362 - minocycline HCl 50 MG Oral Tablet
  • RxCUI: 207362 - minocycline 50 MG Oral Tablet
  • RxCUI: 207362 - minocycline (as minocycline hydrochloride) 50 MG Oral Tablet
  • RxCUI: 207364 - minocycline HCl 100 MG Oral Tablet
  • RxCUI: 207364 - minocycline 100 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA213662
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    59651-337-393000 TABLET, FILM COATED in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59651-337-01?

    The NDC Packaged Code 59651-337-01 is assigned to a package of 100 tablet, film coated in 1 container of Minocycline Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 59651-337 included in the NDC Directory?

    Yes, Minocycline Hydrochloride with product code 59651-337 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on May 01, 2020 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 11-digit format for NDC 59651-337-01?

    The 11-digit format is 59651033701. 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
    5-3-259651-337-015-4-259651-0337-01