Doxycycline Injection, Powder, Lyophilized, For Solution
NDC Package 68083-481-10

11-digit billing NDC: 68083048110
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Doxycycline injection is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, 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 injection, powder, lyophilized, for solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-481 and is authorized under FDA application ANDA215583.

Identification & Billing

NDC Package Code
68083-481-10
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
68083-481
11-Digit Billing Format
68083048110
RxNorm Crosswalk
RxCUI: 310027 - doxycycline hyclate 100 MG Injection

Clinical Specifications

Proprietary Name
Doxycycline
Non-Proprietary Name
Doxycycline
Substance Name
Doxycycline Hyclate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 100 mg/10mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, 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 for Injection, USP is indicated in infections caused by the following microorganisms:Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers).Mycoplasma pneumoniae (PPLO, Eaton Agent).Agents of psittacosis and ornithosis.Agents of lymphogranuloma venereum and granuloma inguinale.The spirochetal agent of relapsing fever (Borrelia recurrentis).The following gram-negative microorganisms:Haemophilus ducreyi (chancroid).Yersinia pestis and Francisella tularensis.Bartonella bacilliformis.Bacteroides species.Vibrio cholerae and Campylobacter fetus.Brucella species (in conjunction with streptomycin).Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, 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.Haemophilus influenzae (respiratory infections).Klebsiella species (respiratory and urinary infections).Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Streptococcus species:Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Enterococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive.   For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.Streptococcus pneumoniae.Staphylococcus aureus, respiratory, skin and soft tissue infections. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.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 drug in the treatment of infections due to:Neisseria gonorrhoeae and N. meningitidis.Treponema pallidum and Treponema pallidum subspecies pertenue (syphilis and yaws).Listeria monocytogenes.Clostridium species.Fusobacterium fusiforme (Vincent's infection).Actinomyces species.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215583
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2023
Listing Expiration
12-31-2027
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 68083-481-10 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial of Doxycycline, a human prescription drug labeled by Gland Pharma Limited. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains doxycycline hyclate 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 Gland Pharma Limited on April 12, 2023. The current certification is valid through December 31, 2027.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083048110. 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)
68083-481-10
11-Digit CMS (5-4-2)
68083-0481-10

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