Doxycycline Hyclate Tablet, Delayed Release
NDC Package 23155-142-05

11-digit billing NDC: 23155014205
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Doxycycline Hyclate tablets is doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for:• Rickettsial infections (1.1)• Sexually transmitted infections (1.2)• Respiratory tract infections (1.3)• Specific bacterial infections (1.4)• Ophthalmic infections (1.5)• Anthrax, including inhalational anthrax (post-exposure) (1.6)• Alternative treatment for selected infections when penicillin is contraindicated (1.7)• Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8)• Prophylaxis of malaria (1.9)UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. This formulation utilizes a tablet, delayed release delivery system. Marketed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc., this product is identified by NDC 23155-142 and is authorized under FDA application ANDA200856.

Identification & Billing

NDC Package Code
23155-142-05
Package Description
500 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
23155-142
11-Digit Billing Format
23155014205
RxNorm Crosswalk
  • RxCUI: 1423080 - doxycycline hyclate 200 MG Delayed Release Oral Tablet
  • RxCUI: 406524 - doxycycline hyclate 75 MG Delayed Release Oral Tablet
  • RxCUI: 434018 - doxycycline hyclate 100 MG Delayed Release Oral Tablet
  • RxCUI: 799048 - doxycycline hyclate 150 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Doxycycline Hyclate Delayed Release
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 100 mg/1
Pharmacologic Class
Usage Information
Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for:• Rickettsial infections (1.1)• Sexually transmitted infections (1.2)• Respiratory tract infections (1.3)• Specific bacterial infections (1.4)• Ophthalmic infections (1.5)• Anthrax, including inhalational anthrax (post-exposure) (1.6)• Alternative treatment for selected infections when penicillin is contraindicated (1.7)• Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8)• Prophylaxis of malaria (1.9)UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10)

Regulatory & Marketing

Labeler Name
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200856
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2013
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 (23155-142). Click a package code to view its specific billing and regulatory data.

23155-142-01
100 TABLET, DELAYED RELEASE in 1 BOTTLE

* 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 23155-142-05 identifies a specific commercial package of 500 tablet, delayed release in 1 bottle of Doxycycline Hyclate Delayed Release, a human prescription drug labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. This tablet, delayed release is formulated for oral 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 Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. on April 30, 2013. The current certification is valid through December 31, 2026.

How is this Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23155014205. 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)
23155-142-05
11-Digit CMS (5-4-2)
23155-0142-05

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