Doxycycline Hyclate
NDC Package 85477-501-05

11-digit billing NDC: 85477050105 · Billing unit: EA · 500 EA per package
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 to reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 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
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets 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
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 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.

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.