Tetracycline Hydrochloride Capsule
NDC Package 0591-2475-01

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

Tetracycline Hydrochloride capsules is to reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride capsules USP and other antibacterial drugs, tetracycline hydrochloride 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 Actavis Pharma, Inc., this product is identified by NDC 0591-2475 and is authorized under FDA application ANDA061837.

Identification & Billing

NDC Package Code
0591-2475-01
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
0591-2475
11-Digit Billing Format
00591247501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tetracycline Hydrochloride
Non-Proprietary Name
Tetracycline Hydrochloride
Substance Name
Tetracycline Hydrochloride
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)
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride capsules USP and other antibacterial drugs, tetracycline 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.Tetracycline hydrochloride, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Haemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.Psittacosis or ornithosis caused by Chlamydia Psittaci.Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.Granuloma inquinale caused by Calymmatobacterium granulomatis.Relapsing fever caused by Borrelia sp.Bartonellosis caused by Bartonella bacilli formis.Chancroid caused by Haemophilus ducreyi.Tularemia caused by Francisella tularensis.Plaque caused by Yersinia pestis.Cholera caused by Vibrio cholerae.Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).Infections due to Campylobacter fetus.As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.In severe acne, adjunctive therapy with tetracycline may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:Syphilis and yaws caused by Treponema pallidum and pertenue, respectively,Vincent’s infection caused by Fuso bacterium fusiforme,Infections caused by Neisseria gonorrhoeae,Anthrax caused by Bacillus anthracis,Infections due to Listeria monocytogenes,Actinomycosis caused by Actinomyces species,Infections due to Clostridium species.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA061837
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0591-2475). Click a package code to view its specific billing and regulatory data.

0591-2475-00
15480 CAPSULE in 1 BOX
0591-2475-10
1000 CAPSULE in 1 BOTTLE, 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 0591-2475-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Tetracycline Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. This capsule is formulated for oral use and contains tetracycline hydrochloride 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 Actavis Pharma, Inc. on August 15, 2011. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591247501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0591-2475-01
11-Digit CMS (5-4-2)
00591-2475-01

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