Doxycycline Hyclate
NDC Package 68382-708-05

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 discontinued by the firm.

Doxycycline Hyclate is a medication used to treat a wide variety of bacterial infections, including those that cause acne. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-708 and is authorized under FDA application ANDA206772.

Identification & Billing

NDC Package Code
68382-708-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
68382-708
11-Digit Billing Format
68382070805

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
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
Zydus Pharmaceuticals Usa Inc.
FDA Application #
ANDA206772
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-21-2018
End Marketing Date
04-07-2025
Listing Expiration
04-07-2025
Exclude Flag
D
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 (68382-708). Click a package code to view its specific billing and regulatory data.

68382-708-01
100 TABLET in 1 BOTTLE
68382-708-14
60 TABLET in 1 BOTTLE
68382-708-77
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (68382-708-30)

* 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 68382-708-05 identifies a specific commercial package of 500 tablet in 1 bottle of Doxycycline Hyclate, labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on December 21, 2018. The current certification is valid through April 07, 2025.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382070805. 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)
68382-708-05
11-Digit CMS (5-4-2)
68382-0708-05

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