Doxycycline Tablet, Coated
NDC Package 70518-3039-2

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

Doxycycline (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, coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-3039 and is authorized under FDA application ANDA065095.

Identification & Billing

NDC Package Code
70518-3039-2
Package Description
60 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
70518-3039
11-Digit Billing Format
70518303902
RxNorm Crosswalk
RxCUI: 1650143 - doxycycline hyclate 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Doxycycline
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 100 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065095
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-3039). Click a package code to view its specific billing and regulatory data.

70518-3039-0
14 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-3039-1
14 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-3039-3
2 POUCH in 1 BOX / 1 TABLET, COATED in 1 POUCH (70518-3039-4)
70518-3039-5
2 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-3039-6
20 TABLET, COATED in 1 BOTTLE, PLASTIC
70518-3039-7
20 TABLET, COATED 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 70518-3039-2 identifies a specific commercial package of 60 tablet, coated in 1 bottle, plastic of Doxycycline, a human prescription drug labeled by Remedyrepack Inc.. This tablet, coated 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 Remedyrepack Inc. on March 04, 2021. 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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518303902. 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 (5-4-1)
70518-3039-2
11-Digit CMS (5-4-2)
70518-3039-02

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