Zohydro Er
NDC Package 65224-310-60

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.

Zohydro Er is hydrocodone is used to help relieve severe ongoing pain. Marketed by Persion Pharmaceuticals Llc, this product is identified by NDC 65224-310 and is authorized under FDA application NDA202880.

Identification & Billing

NDC Package Code
65224-310-60
Package Description
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
65224-310
11-Digit Billing Format
65224031060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Zohydro Er
Dosage Form
-
Usage Information
Hydrocodone is used to help relieve severe ongoing pain. Hydrocodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydrocodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Regulatory & Marketing

Labeler Name
Persion Pharmaceuticals Llc
FDA Application #
NDA202880
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-25-2013
End Marketing Date
05-31-2021
Listing Expiration
05-31-2021
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 65224-310-60 identifies a specific commercial package of 60 capsule, extended release in 1 bottle of Zohydro Er, labeled by Persion Pharmaceuticals 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 Persion Pharmaceuticals Llc on October 25, 2013. The current certification is valid through May 31, 2021.

What are the primary indications for this medication?

Hydrocodone is used to help relieve severe ongoing pain. Hydrocodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydrocodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Persion Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65224031060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
65224-310-60
11-Digit CMS (5-4-2)
65224-0310-60

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