Minocycline Hydrochloride
NDC Package 76519-1043-2

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

Package Information

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

Minocycline Hydrochloride is capsules, USP 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 Chlamydophila 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 urealyticumor 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 Klebsiella granulomatis.Minocycline is indicated for the 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.Minocycline hydrochloride capsules, USP 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 pneumoniae.Skin 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. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 76519-1043 and is authorized under FDA application ANDA065062.

Identification & Billing

NDC Package Code
76519-1043-2
Package Description
20 CAPSULE in 1 VIAL, PLASTIC
Product Code
76519-1043
11-Digit Billing Format
76519104302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Minocycline Hydrochloride
Dosage Form
-
Usage Information
Minocycline hydrochloride capsules, USP 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 Chlamydophila 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 urealyticumor 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 Klebsiella granulomatis.Minocycline is indicated for the 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.Minocycline hydrochloride capsules, USP 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 pneumoniae.Skin 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 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 byMycobacterium marinum.To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, 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.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
ANDA065062
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-28-2016
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76519-1043). Click a package code to view its specific billing and regulatory data.

76519-1043-1
14 CAPSULE in 1 VIAL, PLASTIC
76519-1043-3
30 CAPSULE in 1 VIAL, PLASTIC
76519-1043-4
40 CAPSULE in 1 VIAL, PLASTIC
76519-1043-6
60 CAPSULE in 1 VIAL, PLASTIC
76519-1043-7
7 CAPSULE in 1 VIAL, PLASTIC
76519-1043-9
90 CAPSULE in 1 VIAL, PLASTIC

* 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 76519-1043-2 identifies a specific commercial package of 20 capsule in 1 vial, plastic of Minocycline Hydrochloride, labeled by H.j. Harkins Company, Inc.. 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 H.j. Harkins Company, Inc. on January 28, 2016. The current certification is valid through December 31, 2019.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76519104302. 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)
76519-1043-2
11-Digit CMS (5-4-2)
76519-1043-02

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