Doxycycline Capsule
NDC Package 43386-792-02

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

Package Information

Doxycycline capsules is to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a capsule delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-792 and is authorized under FDA application ANDA204446.

Identification & Billing

NDC Package Code
43386-792-02
Package Description
250 CAPSULE in 1 BOTTLE
Product Code
43386-792
11-Digit Billing Format
43386079202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
250 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Doxycycline
Non-Proprietary Name
Doxycycline
Substance Name
Doxycycline
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE 100 mg/1
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline 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.     Doxycycline is indicated for the treatment of the following infections:     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) caused by 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     Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis     Nongonococcal urethritis caused by Ureaplasma  urealyticum     Relapsing fever due to Borrelia  recurrentis.Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:     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.Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.Doxycycline 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.Doxycycline 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     Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.When penicillin is contraindicated, doxycycline is an alternative  in the treatment of the following infections:     Uncomplicated gonorrhea caused by Neisseria  gonorrhoeae     Syphilis caused by Treponema  pallidum     Yaws caused by Treponema  pertenue     Listeriosis due to Listeria  monocytogenes     Vincent's infection caused by Fusobacterium  fusiforme     Actinomycosis caused by Actinomyces  israelii     Infections caused by Clostridium species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.In severe acne, doxycycline may be useful adjunctive therapy.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204446
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2015
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 43386-792-02 identifies a specific commercial package of 250 capsule in 1 bottle of Doxycycline, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This capsule is formulated for oral use and contains doxycycline 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 Lupin Pharmaceuticals,inc. on July 08, 2015. The current certification is valid through December 31, 2026.

How is this Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386079202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 250 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)
43386-792-02
11-Digit CMS (5-4-2)
43386-0792-02

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