Doxycycline
NDC Package 68645-021-10

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

Package Information

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

Doxycycline is to reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline and other antibacterial drugs, Doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Legacy Pharmaceutical Packaging, this product is identified by NDC 68645-021 and is authorized under FDA application ANDA065095.

Identification & Billing

NDC Package Code
68645-021-10
Package Description
20 TABLET, COATED in 1 BOTTLE
Product Code
68645-021
11-Digit Billing Format
68645002110
RxNorm Crosswalk
RxCUI: 1650143 - doxycycline hyclate 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Doxycycline
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline and other antibacterial drugs, Doxycycline 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.

Regulatory & Marketing

Labeler Name
Legacy Pharmaceutical Packaging
FDA Application #
ANDA065095
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2010
Listing Expiration
12-31-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68645-021-10 identifies a specific commercial package of 20 tablet, coated in 1 bottle of Doxycycline, labeled by Legacy Pharmaceutical Packaging. 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 Legacy Pharmaceutical Packaging on May 01, 2010. The current certification is valid through December 31, 2018.

How is this Legacy Pharmaceutical Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68645002110. 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)
68645-021-10
11-Digit CMS (5-4-2)
68645-0021-10

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