Zohydro
NDC Package 43376-310-60

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 inactivated by the FDA.

Zohydro is ® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.ZOHYDRO ER is not indicated as an as-needed (prn) analgesic. Marketed by Zogenix, Inc., this product is identified by NDC 43376-310 and is authorized under FDA application NDA202880.

Identification & Billing

NDC Package Code
43376-310-60
Package Description
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
43376-310
11-Digit Billing Format
43376031060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1860491 - HYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule
  • RxCUI: 1860491 - 12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule
  • RxCUI: 1860492 - Zohydro ER 10 MG 12HR Extended Release Oral Capsule
  • RxCUI: 1860492 - 12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [Zohydro]
  • RxCUI: 1860492 - 12 HR Zohydro 10 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Zohydro
Dosage Form
-
Usage Information
ZOHYDRO® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.ZOHYDRO ER is not indicated as an as-needed (prn) analgesic.

Regulatory & Marketing

Labeler Name
Zogenix, Inc.
FDA Application #
NDA202880
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-25-2013
Listing Expiration
12-31-2017
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 43376-310-60 identifies a specific commercial package of 60 capsule, extended release in 1 bottle of Zohydro, labeled by Zogenix, 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 Zogenix, Inc. on October 25, 2013. The current certification is valid through December 31, 2017.

How is this Zogenix, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43376031060. 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)
43376-310-60
11-Digit CMS (5-4-2)
43376-0310-60

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