Doxycycline Hyclate
NDC Package 85477-501-05

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 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 Oncora Pharma, Llc, this product is identified by NDC 85477-501 and is authorized under FDA application ANDA210664.

Identification & Billing

NDC Package Code
85477-501-05
Package Description
500 TABLET, COATED in 1 BOTTLE
Product Code
85477-501
11-Digit Billing Format
85477050105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

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
Oncora Pharma, Llc
FDA Application #
ANDA210664
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2020
End Marketing Date
03-01-2026
Listing Expiration
03-01-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85477-501-05 identifies a specific commercial package of 500 tablet, coated in 1 bottle of Doxycycline Hyclate, labeled by Oncora Pharma, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. 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 Oncora Pharma, Llc on August 21, 2020. The current certification is valid through March 01, 2026.

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 Oncora Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85477050105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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 (5-3-2)
85477-501-05
11-Digit CMS (5-4-2)
85477-0501-05

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