Doxycycline Hyclate Tablet, Delayed Release
NDC Package 0591-4575-60

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

Package Information

Doxycycline Hyclate tablets is a medication used to treat a wide variety of bacterial infections, including those that cause acne. This formulation utilizes a tablet, delayed release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-4575 and is authorized under FDA application ANDA090134.

Identification & Billing

NDC Package Code
0591-4575-60
Package Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
0591-4575
11-Digit Billing Format
00591457560
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1423080 - doxycycline hyclate 200 MG Delayed Release Oral Tablet
  • RxCUI: 1653433 - doxycycline hyclate 50 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
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 200 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090134
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-14-2019
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 0591-4575-60 identifies a specific commercial package of 60 tablet, delayed release in 1 bottle of Doxycycline Hyclate, a human prescription drug labeled by Actavis Pharma, 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 Actavis Pharma, Inc. on August 14, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591457560. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
0591-4575-60
11-Digit CMS (5-4-2)
00591-4575-60

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