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  5. NDC Package Code: 76519-1142-6 Tramadol Hydrochloride ER

NDC Package 76519-1142-6 Tramadol Hydrochloride ER

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
76519-1142-6
Package Description:
60 TABLET, EXTENDED RELEASE in 1 VIAL, PLASTIC
Product Code:
76519-1142
Proprietary Name:
Tramadol Hydrochloride ER
Usage Information:
Tramadol hydrochloride is an opioid agonist 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. (1) Limitations of Use Because 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 tramadol hydrochloride extended-release tablets 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. (1) Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)
11-Digit NDC Billing Format:
76519114206
NDC to RxNorm Crosswalk:
  • RxCUI: 833709 - traMADol HCl 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 833709 - 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 833709 - tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet
    • Labeler Name:
    H.j. Harkins Company, Inc.
    Sample Package:
    No
    Start Marketing Date:
    07-15-2016
    Listing Expiration Date:
    12-31-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    76519-1142-330 TABLET, EXTENDED RELEASE in 1 VIAL, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76519-1142-6?

    The NDC Packaged Code 76519-1142-6 is assigned to a package of 60 tablet, extended release in 1 vial, plastic of Tramadol Hydrochloride ER, labeled by H.j. Harkins Company, Inc.. The product's dosage form is and is administered via form.

    Is NDC 76519-1142 included in the NDC Directory?

    No, Tramadol Hydrochloride ER with product code 76519-1142 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by H.j. Harkins Company, Inc. on July 15, 2016 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76519-1142-6?

    The 11-digit format is 76519114206. 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 5-4-1 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
    5-4-176519-1142-65-4-276519-1142-06