Doxycycline Monohydrate
NDC Package 53002-0671-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Doxycycline Monohydrate is a medication used to treat a wide variety of bacterial infections, including those that cause acne. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-0671 and is authorized under FDA application NDA050641.

Identification & Billing

NDC Package Code
53002-0671-2
Package Description
10 CAPSULE in 1 BOTTLE
Product Code
53002-0671
11-Digit Billing Format
53002067102
RxNorm Crosswalk
RxCUI: 1649990 - doxycycline monohydrate 100 MG Oral Capsule

Clinical Specifications

Proprietary Name
Doxycycline Monohydrate
Dosage Form
-
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
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA050641
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-07-2005
Listing Expiration
12-31-2022
Exclude Flag
I
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 (53002-0671). Click a package code to view its specific billing and regulatory data.

53002-0671-0
100 CAPSULE in 1 BOTTLE
53002-0671-1
2 CAPSULE in 1 BOTTLE
53002-0671-3
14 CAPSULE in 1 BOTTLE
53002-0671-4
20 CAPSULE in 1 BOTTLE
53002-0671-5
28 CAPSULE in 1 BOTTLE
53002-0671-6
30 CAPSULE in 1 BOTTLE
53002-0671-7
40 CAPSULE in 1 BOTTLE
53002-0671-9
60 CAPSULE 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 53002-0671-2 identifies a specific commercial package of 10 capsule in 1 bottle of Doxycycline Monohydrate, labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on February 07, 2005. The current certification is valid through December 31, 2022.

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 Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002067102. 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)
53002-0671-2
11-Digit CMS (5-4-2)
53002-0671-02

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