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  5. NDC Package Code: 43376-250-10 Zohydro

NDC Package 43376-250-10 Zohydro

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43376-250-10
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
43376-250
Proprietary Name:
Zohydro
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.
11-Digit NDC Billing Format:
43376025010
NDC to 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
    • Labeler Name:
    Zogenix, Inc.
    Sample Package:
    No
    Start Marketing Date:
    10-25-2013
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 43376-250-10?

    The NDC Packaged Code 43376-250-10 is assigned to a package of 100 capsule, extended release in 1 bottle of Zohydro, labeled by Zogenix, Inc.. The product's dosage form is and is administered via form.

    Is NDC 43376-250 included in the NDC Directory?

    No, Zohydro with product code 43376-250 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Zogenix, Inc. on October 25, 2013 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 43376-250-10?

    The 11-digit format is 43376025010. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243376-250-105-4-243376-0250-10